{"success":true,"data":{"pressRelease":{"id":"178778","rtpr_id":"nPn9R5719a-20261023","ticker":"ABBV","exchange":"NYSE","all_tickers":["ABBV"],"title":"U.S. FDA Approves Subcutaneous Induction Regimen for AbbVie's SKYRIZI® (risankizumab-rzaa) for Adults With Moderately to Severely Active Crohn's Disease","author":"PR Newswire","published_at":"2026-10-23T19:33:57.837Z","article_body":"U.S. FDA Approves Subcutaneous Induction Regimen for AbbVie's SKYRIZI® (risankizumab-rzaa) for Adults With Moderately to Severely Active Crohn's Disease\nPR Newswire\n\nNORTH CHICAGO, Ill., Oct. 23, 2026\n\n * Now with a new route of induction administration, subcutaneous SKYRIZI\nsupports early symptomatic and endoscopic control with an on-body injector\n(OBI) device throughout the course of treatment\n * In the pivotal Phase 3 AFFIRM study, subcutaneous (SC) SKYRIZI(® )achieved\nsuperior clinical remission(i) and endoscopic response(ii) at week 12 compared\nwith placebo in patients with Crohn's disease; results were particularly\nstrong in patients without prior advanced therapy failure(iii)\n * The safety profile of subcutaneous induction was generally consistent with the\nestablished SKYRIZI profile in Crohn's disease, with no new safety risks\nidentified\n * FDA also approved an update to the U.S. Prescribing Information warning and\nprecautions across all indications to allow healthcare providers to use\nclinical judgment when determining whether tuberculosis (TB) testing is needed\nNORTH CHICAGO, Ill., Oct. 23, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today\nannounced the U.S. Food and Drug Administration has approved a subcutaneous\n(SC) induction regimen for SKYRIZI(®) (risankizumab-rzaa) for adults with\nmoderately to severely active Crohn's disease (CD)(iv). Patients now have the\noption to start SKYRIZI treatment at home, with induction doses delivered by\nan on-body injector (OBI) induction pack and then continue using an OBI once\nevery eight weeks throughout the course of maintenance treatment.\n\n\"People living with Crohn's disease need treatments that can deliver\nmeaningful disease control from the start,\" said Roopal Thakkar, M.D.,\nexecutive vice president, research and development, chief scientific officer,\nAbbVie. \"With the approval of subcutaneous induction, we are building on the\nstrong efficacy of SKYRIZI while giving patients and physicians greater\nflexibility in how treatment is initiated. This is one more example of how\nAbbVie continues to advance treatment to better meet the needs of people\nliving with Crohn's disease.\"\n\nSubcutaneous SKYRIZI Shows High Rates of Clinical Remission and Endoscopic\nResponse by Week 12(iii)\nThis FDA approval is supported by positive results\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4803447-1&h=3124998267&u=https%3A%2F%2Fnews.abbvie.com%2F2026-03-02-AbbVie-Announces-Positive-Topline-Results-from-Phase-3-AFFIRM-Study-Evaluating-SKYRIZI-R-Risankizumab-Subcutaneous-Induction-in-Patients-with-Crohns-Disease&a=positive+results)\nfrom the Phase 3 AFFIRM trial evaluating the efficacy and safety of SC SKYRIZI\nversus placebo in patients with moderately to severely active CD.(iii) SKYRIZI\nachieved superiority of the co-primary endpoints of clinical remission and\nendoscopic response at week 12.(iii) Although the study enrolled a primarily\ntreatment-refractory population, these Phase 3 results were particularly\nstrong within patients without prior advanced therapy failure (advanced\ntherapy-naïve).(iii) By week 12, nearly three-quarters (74%) of advanced\ntherapy (AT)-naïve patients were in clinical remission (vs. 27% placebo) and\nthese AT-naïve patients achieved endoscopic response at four times the rate\nof placebo (60% vs. 15%, respectively).(iii) SC SKYRIZI also had a higher\nefficacy response in patients who had previously failed advanced therapy.(iii)\n\nSC SKYRIZI also met secondary endpoints including endoscopic remission and\nFACIT fatigue scores at week 12 vs. placebo.(iii) The safety profile of SC\nSKYRIZI for induction was generally consistent with its known profile in CD,\nwith no new safety risks observed.(iii)\n\nTogether, these results demonstrate market-leading clinical and endoscopic\noutcomes in advanced therapy-naïve patients that set a high bar in CD.\nFurthermore, the strength of these subcutaneous results provides a compelling\nfoundation for future clinical trials.\n AFFIRM Phase 3 Proportion of Patients Meeting Efficacy Endpoints at Week\n 12(iii)\n                  Total Population          Prior Advanced Therapy       Without Prior Advanced\n                                            Failure(a)                   Therapy Failure(b)\n                                                                         (Advanced Therapy-Naïve)\n Proportion of    Placebo    Skyrizi SC(c)  Placebo       Skyrizi SC(c)  Placebo         Skyrizi SC(c)\n Patients\nN=94\nN=180\nN=61\nN=115\nN=33\nN=65\n Clinical         30 %       56 %(h)        31 %          45 %           27 %            74 %\n Remission(d,e)\n Endoscopic       15 %       43 %(h)        15 %          33 %           15 %            60 %\n Response(d,f)\n Endoscopic       11 %       26 %(h)        11 %          17 %           9 %             43 %\n Remission(g)\n a. Prior advanced therapy failure includes inadequate response, loss of\n response, or intolerance to one or more biologic or Janus Kinase inhibitor\n (JAKi) treatments for CD\n\nb. Without prior advanced therapy failure includes patients who were naïve to\n biologics or JAKi, or patients who had never failed or demonstrated\n intolerance to biologics or JAKi\n\nc. SKYRIZI 720 mg as a subcutaneous injection at Week 0, Week 2, Week 4, and\n Week 8\n\nd. Co-primary endpoints\n\ne. Defined as Crohn's disease activity index (CDAI) < 150\n\nf.  Defined as a decrease in Simplified Endoscopic Activity Score for Crohn's\n disease (SES-CD) > 50% from baseline, or a decrease of at least 2 points\n for subjects with a baseline\n     score of 4 and isolated ileal disease, based on central reading\n\ng. SES-CD ≤ 4 and at least a 2-point reduction from baseline, with no\n individual subscore greater than 1, based on central reading\n h. p <0.001 compared to placebo in total population.\n\nSubcutaneous Treatment With SKYRIZI Offers Fully Self-Administered Therapy\nFrom the Start\nThe induction dosing regimen with SC SKYRIZI is 720 mg delivered by OBI\ninduction pack at weeks 0, 2, 4 and 8.(iii) Patients also have the option to\nstart treatment intravenously with 600 mg delivered at weeks 0, 4 and 8.(iii)\nPatients can then continue with maintenance dosing starting at week 12\nadministered by OBI every eight weeks.(iii)\n\n\"When patients and I discuss treatment, they want to know two things: will it\nwork? And how will it fit into their lives?\" said Millie D. Long, M.D., MPH,\nchief, division of gastroenterology and hepatology, University of North\nCarolina at Chapel Hill, and lead investigator of AFFIRM. \"AFFIRM answered\nthe first question, with superior rates of clinical remission and endoscopic\nresponse versus placebo during induction with subcutaneous SKYRIZI,\nparticularly in patients new to advanced therapy. This approval answers the\nsecond. As a physician who has used the SKYRIZI OBI, I've seen firsthand the\nconvenience it can offer patients. Now with this approval, patients can start\ntreatment at home and continue the same way through maintenance.\"\n\nPatients Report Satisfaction and Ease of Use in Real World Experience With\nSKYRIZI OBI\nFirst introduced in 2022 for CD maintenance treatment, the SKYRIZI OBI has\ndemonstrated strong user experience. In a real-world survey of 186 people\nliving with CD, 88% reported AbbVie's OBI easy to use.(v) In evaluating\nalternative routes of administration, a patient-reported survey of 352 adults\nliving with IBD found 87% were satisfied or highly satisfied with OBI compared\nto 71% with an autoinjector(vi), demonstrating patient preference for OBI.\n\nFDA Also Approved Update to Tuberculosis (TB) Language in U.S. Prescribing\nInformation\nAdditionally, the FDA approved an update to the SKYRIZI prescribing\ninformation's warning and precautions language across all approved\nindications.(iii) The revised label advises healthcare providers to consider\nTB evaluation prior to treatment initiation based on clinical judgment.(iii)\nThis change gives healthcare providers greater flexibility in patient\nassessment before starting SKYRIZI treatment. There is no mandatory TB test\nprior to initiating SKYRIZI.\n\nAbout Crohn's Disease\nCrohn's disease is a chronic, systemic disease that manifests as inflammation\nwithin the gastrointestinal tract, most commonly in the area between the small\nintestine (ileum) and the colon, causing persistent diarrhea and abdominal\npain.(vii,viii) It is a progressive disease, meaning it gets worse over time\nand may lead to life-threatening complications or surgery.(ix,x) Because the\nsigns and symptoms of Crohn's disease are unpredictable, it causes a\nsignificant burden on people living with the disease—not only physically but\nalso emotionally and economically.(xi)\n\nAbout the AFFIRM Study(x)(ii)\nAFFIRM is a global, Phase 3, randomized, placebo-controlled, double-blind\nstudy to evaluate the efficacy and safety of risankizumab subcutaneous (SC) as\nan induction treatment in adult patients with moderately to severely active\nCrohn's disease. Co-primary endpoints were percentage of participants with\nCDAI Clinical Remission (CDAI < 150) and percentage of participants with\nendoscopic response at week 12. A total of 274 patients were randomized in a\n2:1 ratio to risankizumab SC or placebo. Key demographics and baseline\ncharacteristics were generally balanced between the risankizumab SC and\nplacebo groups; 65% had failed advanced therapies for the treatment of CD\nbefore. The study consists of three treatment periods: a placebo-controlled\nPeriod A (baseline to week 12) to evaluate the efficacy and safety of\nrisankizumab SC induction treatment, an extended Period B (week 12 to 24)\nwhere patients receive blinded or open-label treatments based on their\nclinical response at week 12, and a 52-week open-label extension Period C\nwhere all patients receive the approved risankizumab maintenance\ntreatment.(x)(ii) More information on this trial can be found\nat www.clinicaltrials.gov (http://www.clinicaltrials.gov)  (NCT06063967\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4803447-1&h=394422731&u=https%3A%2F%2Fedge.prnewswire.com%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4629860-1%26h%3D4265247759%26u%3Dhttps%253A%252F%252Fclinicaltrials.gov%252Fstudy%252FNCT06063967%253Fterm%253DNCT06063967%2526rank%253D1%26a%3DNCT06063967&a=NCT06063967)\n).(xii)\n\nPatient Access and Support\nAbbVie is committed to helping people access SKYRIZI and other medicines,\nincluding offering a patient support program and co-pay card that may reduce\nout-of-pocket costs to as little as $0 per month for eligible, commercially\ninsured patients. For those with limited or no health insurance, AbbVie offers\nmyAbbVie Assist, a patient assistance program that provides SKYRIZI at no\ncharge to those who qualify. More information about this assistance program\ncan be found at www.AbbVie.com/myAbbVieAssist\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4803447-1&h=3910935453&u=https%3A%2F%2Fedge.prnewswire.com%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4710081-1%26h%3D440661190%26u%3Dhttps%253A%252F%252Fwww.abbvie.com%252FmyAbbVieAssist%26a%3Dwww.AbbVie.com%252FmyAbbVieAssist&a=www.AbbVie.com%2FmyAbbVieAssist)\n.\n\nAbout SKYRIZI(® )(risankizumab-rzaa)\nSKYRIZI is an interleukin-23 (IL-23) inhibitor that blocks IL-23 by\nselectively binding to its p19 subunit. IL-23, a cytokine involved in\ninflammatory processes, is thought to be linked to a number of chronic\nimmune-mediated diseases.(iii) SKYRIZI is approved by the U.S. Food and Drug\nAdministration (FDA) for the treatment of moderately to severely active\nulcerative colitis, plaque psoriasis, psoriatic arthritis and Crohn's\ndisease.(iii)\n\nSKYRIZI(®) (risankizumab-rzaa) U.S. Uses and Important Safety\nInformation(iii\n)SKYRIZI is a prescription medicine used to treat:\n\n * moderate to severe plaque psoriasis in adults and children 6 years of age and\nolder who may benefit from taking injections or pills (systemic therapy) or\ntreatment using ultraviolet or UV light (phototherapy).\n * active psoriatic arthritis in adults and children 6 years of age and older.\n * moderately to severely active Crohn's disease in adults.\n * moderately to severely active ulcerative colitis in adults.\nIMPORTANT SAFETY INFORMATION\n\nWhat is the most important information I should know about\nSKYRIZI(®) (risankizumab-rzaa)?\n\nSKYRIZI is a prescription medicine that may cause serious side effects,\nincluding:\n\nSerious allergic reactions:\n\n * Stop using SKYRIZI and get emergency medical help right away if you get any of\nthe following symptoms of a serious allergic reaction:\n* fainting, dizziness, feeling lightheaded (low blood pressure)\n * swelling of your face, eyelids, lips, mouth, tongue, or throat\n * trouble breathing or throat tightness\n * chest tightness\n * skin rash, hives\n * itching\nInfections:\nSKYRIZI may lower the ability of your immune system to fight infections and\nmay increase your risk of infections. Your healthcare provider may check you\nfor infections and tuberculosis (TB) before starting treatment with SKYRIZI\nand may treat you for TB before you begin treatment with SKYRIZI if you have a\nhistory of TB or have active TB. Your healthcare provider should watch you\nclosely for signs and symptoms of TB during and after treatment with SKYRIZI.\n\n * Tell your healthcare provider right away if you have an infection or have\nsymptoms of an infection, including:\n* fever, sweats, or chills\n * cough\n * shortness of breath\n * blood in your mucus (phlegm)\n * muscle aches\n * warm, red, or painful skin or sores on your body different from your psoriasis\n * weight loss\n * diarrhea or stomach pain\n * burning when you urinate or urinating more often than normal\nDo not use SKYRIZI if you are allergic to risankizumab-rzaa or any of the\ningredients in SKYRIZI. See the Medication Guide or Consumer Brief Summary for\na complete list of ingredients.\n\nBefore using SKYRIZI, tell your healthcare provider about all of your medical\nconditions, including if you:\n\n * have any of the conditions or symptoms listed in the section \"What is the most\nimportant information I should know about SKYRIZI?\"\n * have an infection that does not go away or that keeps coming back.\n * have TB or have been in close contact with someone with TB.\n * have recently received or are scheduled to receive an immunization (vaccine).\nMedications that interact with the immune system may increase your risk of\ngetting an infection after receiving live vaccines. You should avoid receiving\nlive vaccines right before, during, or right after treatment with SKYRIZI.\nTell your healthcare provider that you are taking SKYRIZI before receiving a\nvaccine.\n * are pregnant or plan to become pregnant. It is not known if SKYRIZI can harm\nyour unborn baby.\n * are breastfeeding or plan to breastfeed. It is not known if SKYRIZI passes\ninto your breast milk.\n * become pregnant while taking SKYRIZI. You are encouraged to enroll in the\nPregnancy Registry, which is used to collect information about the health of\nyou and your baby. Talk to your healthcare provider or call 1-877-302-2161 or\nvisit\nhttp://glowpregnancyregistry.com (http://glowpregnancyregistry.com)\nto enroll in this registry.\nTell your healthcare provider about all the medicines you take, including\nprescription and over-the-counter medicines, vitamins, and herbal supplements.\n\nWhat are the possible side effects of SKYRIZI?\n\nSKYRIZI may cause serious side effects. See \"What is the most important\ninformation I should know about SKYRIZI?\"\n\nLiver problems may happen while being treated for Crohn's disease or\nulcerative colitis: A person with Crohn's disease who received SKYRIZI through\na vein in the arm developed changes in liver blood tests with a rash that led\nto hospitalization. Your healthcare provider will do blood tests to check your\nliver before, during, and at least up to 12 weeks of treatment, and may stop\ntreatment with SKYRIZI if you develop liver problems. Tell your healthcare\nprovider right away if you notice any of the following symptoms: unexplained\nrash, nausea, vomiting, stomach (abdominal) pain, tiredness (fatigue), loss of\nappetite, yellowing of the skin and eyes (jaundice), and dark urine.\n\nThe most common side effects of SKYRIZI in people treated for Crohn's disease\nand ulcerative colitis include: upper respiratory infections, headache, joint\npain, stomach (abdominal) pain, injection site reactions, low red blood cells\n(anemia), fever, back pain, urinary tract infection, and rash.\n\nThe most common side effects of SKYRIZI in people treated for plaque psoriasis\nand psoriatic arthritis include: upper respiratory infections, headache,\nfeeling tired, injection site reactions, and fungal skin infections.\n\nThese are not all the possible side effects of SKYRIZI. Call your doctor for\nmedical advice about side effects.\n\nUse SKYRIZI exactly as your healthcare provider tells you to use it.\n\nSKYRIZI (risankizumab-rzaa) is available in a 150 mg/mL prefilled syringe and\npen, a 55 mg/0.37 mL prefilled syringe, a 600 mg/10 mL vial for intravenous\ninfusion, and a 180 mg/1.2 mL or 360 mg/2.4 mL single-dose prefilled cartridge\nwith on-body injector.\n\nYou are encouraged to report negative side effects of prescription drugs to\nthe FDA. Visit www.fda.gov/medwatch\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4803447-1&h=1318714086&u=https%3A%2F%2Fwww.fda.gov%2Fsafety%2Fmedwatch-fda-safety-information-and-adverse-event-reporting-program&a=www.fda.gov%2Fmedwatch)\nor call 1-800-FDA-1088.\n\nIf you are having difficulty paying for your medicine, AbbVie may be able to\nhelp.\n\nVisit AbbVie.com/PatientAccessSupport\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4803447-1&h=2300629693&u=https%3A%2F%2Fwww.abbvie.com%2Fpatientaccesssupport&a=AbbVie.com%2FPatientAccessSupport)\n to learn more.\n\nPlease click here for the Full Prescribing Information\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4803447-1&h=3631654216&u=https%3A%2F%2Fwww.rxabbvie.com%2Fpdf%2Fskyrizi_pi.pdf&a=Full+Prescribing+Information%C2%A0)\nand Medication Guide\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4803447-1&h=1846813211&u=https%3A%2F%2Fwww.rxabbvie.com%2Fpdf%2Fskyrizi_medguide.pdf&a=Medication+Guide)\n.\n\nAbout AbbVie\nAbbVie's mission is to discover and deliver innovative medicines and solutions\nthat solve serious health issues today and address the medical challenges of\ntomorrow. We strive to have a remarkable impact on people's lives across\nseveral key therapeutic areas including immunology, neuroscience and oncology\n– and products and services in our Allergan Aesthetics portfolio. For more\ninformation about AbbVie, please visit us at www.abbvie.com\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4803447-1&h=3066344002&u=http%3A%2F%2Fwww.abbvie.com%2F&a=www.abbvie.com)\n. Follow @abbvie on LinkedIn,\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4803447-1&h=3713524754&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fabbvie%2F&a=LinkedIn%2C)\n Facebook\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4803447-1&h=3161849456&u=https%3A%2F%2Fwww.facebook.com%2FAbbVieGlobal%2F&a=Facebook)\n, Instagram\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4803447-1&h=3763518550&u=https%3A%2F%2Fwww.instagram.com%2Fabbvie%2F&a=Instagram)\n, X\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4803447-1&h=3218184354&u=https%3A%2F%2Ftwitter.com%2Fabbvie&a=X)\n and YouTube.\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4803447-1&h=251236895&u=https%3A%2F%2Fwww.youtube.com%2Fuser%2FAbbVie&a=YouTube.)\n\nAbout AbbVie in Immunology\nAbbVie is relentless in our pursuit to redefine the standard of care for\npatients living with immune-mediated conditions, with the goal of helping them\nlive a life free from the limitations of their disease. For nearly 30 years,\nAbbVie has led and helped shape the field of immunology through groundbreaking\nscience and trusted medicines. Building on deep expertise across\ngastroenterology, rheumatology, dermatology and other areas of high unmet\nneed, we continue to invest in a broad and differentiated pipeline –\nspanning innovative modalities, novel mechanisms of action and next-generation\napproaches designed to conquer the complex biology underlying immune-mediated\ndisease.\n\nToday, more than 1 million patients worldwide are treated with AbbVie's\nimmunology medicines, approved in more than 175 countries across 20+\nimmune-mediated diseases that impact adult and pediatric populations. As we\nwork to strengthen our legacy and drive the next wave of innovation, we remain\nfocused on delivering meaningful progress for patients and expanding access to\nour medicines. For more information, please visit www.abbvie.com/immunology\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4803447-1&h=791845188&u=https%3A%2F%2Fwww.abbvie.com%2Fscience%2Fareas-of-focus%2Fimmunology.html&a=www.abbvie.com%2Fimmunology)\n.\n\nForward-Looking Statements\nSome statements in this news release are, or may be considered,\nforward-looking statements for purposes of the Private Securities Litigation\nReform Act of 1995. The words \"believe,\" \"expect,\" \"anticipate,\" \"project\" and\nsimilar expressions and uses of future or conditional verbs, generally\nidentify forward-looking statements. AbbVie cautions that these\nforward-looking statements are subject to risks and uncertainties that may\ncause actual results to differ materially from those expressed or implied in\nthe forward-looking statements. Such risks and uncertainties include, but are\nnot limited to, challenges to intellectual property, competition from other\nproducts, difficulties inherent in the research and development process,\nadverse litigation or government action, changes to laws and regulations\napplicable to our industry, the impact of global macroeconomic factors, such\nas economic downturns or uncertainty, international conflict, trade disputes\nand tariffs, and other uncertainties and risks associated with global business\noperations. Additional information about the economic, competitive,\ngovernmental, technological and other factors that may affect AbbVie's\noperations is set forth in Item 1A, \"Risk Factors,\" of AbbVie's 2025 Annual\nReport on Form 10-K, which has been filed with the Securities and Exchange\nCommission, as updated by its Quarterly Reports on Form 10-Q and in other\ndocuments that AbbVie subsequently files with the Securities and Exchange\nCommission that update, supplement or supersede such information. AbbVie\nundertakes no obligation, and specifically declines, to release publicly any\nrevisions to forward-looking statements as a result of subsequent events or\ndevelopments, except as required by law.\n U.S. Media:                                                             Investors:\n\nJasmine Farley\nLiz Shea\n\n+1 (847) 309-2779\n+1 (847) 935-2211\n\nJasmine.Farley@abbvie.com (mailto:Jasmine.Farley@abbvie.com)\nLiz.Shea@abbvie.com (mailto:Liz.Shea@abbvie.com)\n\nGlobal Media:\n\nGiovanna Chandler\n\n+1 (571) 867-1967\n\nGiovanna.Chandler@abbvie.com (mailto:Giovanna.Chandler@abbvie.com)\n\nReferences:\ni. Co-primary endpoint defined as Crohn's Disease Activity Index (CDAI) score\n<150.\nii. Co-primary endpoint defined as decrease in SES-CD > 50% from\nbaseline (or for patients with isolated ileal disease and a baseline SES-CD of\n4, at least a 2-point reduction from baseline), as scored by a central\nreviewer.\niii. SKYRIZI [Package Insert]. North Chicago, IL: AbbVie Inc.\niv. Defined as CDAI of 220 to 450 and SES-CD ≥ 6 (or ≥ 4 for isolated\nileal disease).\nv. Keefer L, Griffith JM, Yang M, et al. Treatment satisfaction and patients'\nexperiences with risankizumab on-body injector among adults with Crohn's\ndisease in clinical practice: initial results from the ASPIRE-CD study. Poster\nP5425. Presented at: American College of Gastroenterology Annual Scientific\nMeeting; October 24-29, 2025; Phoenix, AZ.\nvi. Data on file, AbbVie Inc. Source: ZS Associates; December 2024-February\n2025.\nvii. Crohn's & Colitis Foundation. The facts about inflammatory bowel\ndiseases. Crohn's & Colitis Foundation. Published November 2014. Accessed\nOctober 13, 2026.\nhttps://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4803447-1&h=231462167&u=https%3A%2F%2Fwww.crohnscolitisfoundation.org%2Fsites%2Fdefault%2Ffiles%2F2019-02%2FUpdated%2520IBD%2520Factbook.pdf&a=https%3A%2F%2Fwww.crohnscolitisfoundation.org%2Fsites%2Fdefault%2Ffiles%2F2019-02%2FUpdated%2520IBD%2520Factbook.pdf)\n.\nviii. Mayo Clinic. Crohn's disease - Symptoms and causes. Mayo Clinic.\nAccessed February 23, 2026.\nhttps://www.mayoclinic.org/diseases-conditions/crohns-disease/symptoms-causes/syc-20353304\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4803447-1&h=3194509179&u=https%3A%2F%2Fwww.mayoclinic.org%2Fdiseases-conditions%2Fcrohns-disease%2Fsymptoms-causes%2Fsyc-20353304&a=https%3A%2F%2Fwww.mayoclinic.org%2Fdiseases-conditions%2Fcrohns-disease%2Fsymptoms-causes%2Fsyc-20353304)\n.\nix. Mehta F. Report: economic implications of inflammatory bowel disease and\nits management. Am J Manag Care. 2016 Mar;22(3 Suppl):s51-60.\nx. Kaplan G. The global burden of IBD: from 2015 to 2025. Nat Rev\nGastroenterol Hepatol. 2015 Dec;12(12):720-7. doi: 10.1038/nrgastro.2015.150.\nxi. Gajendran M, et al. A comprehensive review and update on Crohn's disease.\nDis Mon. 2018 Feb;64(2):20-57. doi: 10.1016/j.disamonth.2017.07.001.\nxii. ClinicalTrials.gov. A Study to Evaluate Efficacy and Safety of\nRisankizumab Subcutaneous Induction in Participants With Moderately to\nSeverely Active Crohn's Disease (AFFIRM). NCT06063967. Available\nat: https://clinicaltrials.gov/study/NCT06063967\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4803447-1&h=155623405&u=https%3A%2F%2Fedge.prnewswire.com%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4803447-1%26h%3D2888818247%26u%3Dhttps%253A%252F%252Fclinicaltrials.gov%252Fstudy%252FNCT06063967%26a%3Dhttps%253A%252F%252Fclinicaltrials.gov%252Fstudy%252FNCT06063967&a=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT06063967)\n. Accessed October 13, 2026.\n\n \n\nView original\ncontent:https://www.prnewswire.com/news-releases/us-fda-approves-subcutaneous-induction-regimen-for-abbvies-skyrizi-risankizumab-rzaa-for-adults-with-moderately-to-severely-active-crohns-disease-302918434.html\n(https://www.prnewswire.com/news-releases/us-fda-approves-subcutaneous-induction-regimen-for-abbvies-skyrizi-risankizumab-rzaa-for-adults-with-moderately-to-severely-active-crohns-disease-302918434.html)\n\nSOURCE AbbVie\n\n\n\nCopyright (c) 2026 PR Newswire Association,LLC. All Rights Reserved.","article_body_html":"","raw_payload":{"data":{"id":"nPn9R5719a-20261023","title":"U.S. FDA Approves Subcutaneous Induction Regimen for AbbVie's SKYRIZI® (risankizumab-rzaa) for Adults With Moderately to Severely Active Crohn's Disease","author":"PR Newswire","ticker":"ABBV","created":"2026-10-23T19:33:57.837Z","tickers":["ABBV"],"exchange":"NYSE","article_body":"U.S. FDA Approves Subcutaneous Induction Regimen for AbbVie's SKYRIZI® (risankizumab-rzaa) for Adults With Moderately to Severely Active Crohn's Disease\nPR Newswire\n\nNORTH CHICAGO, Ill., Oct. 23, 2026\n\n * Now with a new route of induction administration, subcutaneous SKYRIZI\nsupports early symptomatic and endoscopic control with an on-body injector\n(OBI) device throughout the course of treatment\n * In the pivotal Phase 3 AFFIRM study, subcutaneous (SC) SKYRIZI(® )achieved\nsuperior clinical remission(i) and endoscopic response(ii) at week 12 compared\nwith placebo in patients with Crohn's disease; results were particularly\nstrong in patients without prior advanced therapy failure(iii)\n * The safety profile of subcutaneous induction was generally consistent with the\nestablished SKYRIZI profile in Crohn's disease, with no new safety risks\nidentified\n * FDA also approved an update to the U.S. Prescribing Information warning and\nprecautions across all indications to allow healthcare providers to use\nclinical judgment when determining whether tuberculosis (TB) testing is needed\nNORTH CHICAGO, Ill., Oct. 23, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today\nannounced the U.S. Food and Drug Administration has approved a subcutaneous\n(SC) induction regimen for SKYRIZI(®) (risankizumab-rzaa) for adults with\nmoderately to severely active Crohn's disease (CD)(iv). Patients now have the\noption to start SKYRIZI treatment at home, with induction doses delivered by\nan on-body injector (OBI) induction pack and then continue using an OBI once\nevery eight weeks throughout the course of maintenance treatment.\n\n\"People living with Crohn's disease need treatments that can deliver\nmeaningful disease control from the start,\" said Roopal Thakkar, M.D.,\nexecutive vice president, research and development, chief scientific officer,\nAbbVie. \"With the approval of subcutaneous induction, we are building on the\nstrong efficacy of SKYRIZI while giving patients and physicians greater\nflexibility in how treatment is initiated. This is one more example of how\nAbbVie continues to advance treatment to better meet the needs of people\nliving with Crohn's disease.\"\n\nSubcutaneous SKYRIZI Shows High Rates of Clinical Remission and Endoscopic\nResponse by Week 12(iii)\nThis FDA approval is supported by positive results\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4803447-1&h=3124998267&u=https%3A%2F%2Fnews.abbvie.com%2F2026-03-02-AbbVie-Announces-Positive-Topline-Results-from-Phase-3-AFFIRM-Study-Evaluating-SKYRIZI-R-Risankizumab-Subcutaneous-Induction-in-Patients-with-Crohns-Disease&a=positive+results)\nfrom the Phase 3 AFFIRM trial evaluating the efficacy and safety of SC SKYRIZI\nversus placebo in patients with moderately to severely active CD.(iii) SKYRIZI\nachieved superiority of the co-primary endpoints of clinical remission and\nendoscopic response at week 12.(iii) Although the study enrolled a primarily\ntreatment-refractory population, these Phase 3 results were particularly\nstrong within patients without prior advanced therapy failure (advanced\ntherapy-naïve).(iii) By week 12, nearly three-quarters (74%) of advanced\ntherapy (AT)-naïve patients were in clinical remission (vs. 27% placebo) and\nthese AT-naïve patients achieved endoscopic response at four times the rate\nof placebo (60% vs. 15%, respectively).(iii) SC SKYRIZI also had a higher\nefficacy response in patients who had previously failed advanced therapy.(iii)\n\nSC SKYRIZI also met secondary endpoints including endoscopic remission and\nFACIT fatigue scores at week 12 vs. placebo.(iii) The safety profile of SC\nSKYRIZI for induction was generally consistent with its known profile in CD,\nwith no new safety risks observed.(iii)\n\nTogether, these results demonstrate market-leading clinical and endoscopic\noutcomes in advanced therapy-naïve patients that set a high bar in CD.\nFurthermore, the strength of these subcutaneous results provides a compelling\nfoundation for future clinical trials.\n AFFIRM Phase 3 Proportion of Patients Meeting Efficacy Endpoints at Week\n 12(iii)\n                  Total Population          Prior Advanced Therapy       Without Prior Advanced\n                                            Failure(a)                   Therapy Failure(b)\n                                                                         (Advanced Therapy-Naïve)\n Proportion of    Placebo    Skyrizi SC(c)  Placebo       Skyrizi SC(c)  Placebo         Skyrizi SC(c)\n Patients\nN=94\nN=180\nN=61\nN=115\nN=33\nN=65\n Clinical         30 %       56 %(h)        31 %          45 %           27 %            74 %\n Remission(d,e)\n Endoscopic       15 %       43 %(h)        15 %          33 %           15 %            60 %\n Response(d,f)\n Endoscopic       11 %       26 %(h)        11 %          17 %           9 %             43 %\n Remission(g)\n a. Prior advanced therapy failure includes inadequate response, loss of\n response, or intolerance to one or more biologic or Janus Kinase inhibitor\n (JAKi) treatments for CD\n\nb. Without prior advanced therapy failure includes patients who were naïve to\n biologics or JAKi, or patients who had never failed or demonstrated\n intolerance to biologics or JAKi\n\nc. SKYRIZI 720 mg as a subcutaneous injection at Week 0, Week 2, Week 4, and\n Week 8\n\nd. Co-primary endpoints\n\ne. Defined as Crohn's disease activity index (CDAI) < 150\n\nf.  Defined as a decrease in Simplified Endoscopic Activity Score for Crohn's\n disease (SES-CD) > 50% from baseline, or a decrease of at least 2 points\n for subjects with a baseline\n     score of 4 and isolated ileal disease, based on central reading\n\ng. SES-CD ≤ 4 and at least a 2-point reduction from baseline, with no\n individual subscore greater than 1, based on central reading\n h. p <0.001 compared to placebo in total population.\n\nSubcutaneous Treatment With SKYRIZI Offers Fully Self-Administered Therapy\nFrom the Start\nThe induction dosing regimen with SC SKYRIZI is 720 mg delivered by OBI\ninduction pack at weeks 0, 2, 4 and 8.(iii) Patients also have the option to\nstart treatment intravenously with 600 mg delivered at weeks 0, 4 and 8.(iii)\nPatients can then continue with maintenance dosing starting at week 12\nadministered by OBI every eight weeks.(iii)\n\n\"When patients and I discuss treatment, they want to know two things: will it\nwork? And how will it fit into their lives?\" said Millie D. Long, M.D., MPH,\nchief, division of gastroenterology and hepatology, University of North\nCarolina at Chapel Hill, and lead investigator of AFFIRM. \"AFFIRM answered\nthe first question, with superior rates of clinical remission and endoscopic\nresponse versus placebo during induction with subcutaneous SKYRIZI,\nparticularly in patients new to advanced therapy. This approval answers the\nsecond. As a physician who has used the SKYRIZI OBI, I've seen firsthand the\nconvenience it can offer patients. Now with this approval, patients can start\ntreatment at home and continue the same way through maintenance.\"\n\nPatients Report Satisfaction and Ease of Use in Real World Experience With\nSKYRIZI OBI\nFirst introduced in 2022 for CD maintenance treatment, the SKYRIZI OBI has\ndemonstrated strong user experience. In a real-world survey of 186 people\nliving with CD, 88% reported AbbVie's OBI easy to use.(v) In evaluating\nalternative routes of administration, a patient-reported survey of 352 adults\nliving with IBD found 87% were satisfied or highly satisfied with OBI compared\nto 71% with an autoinjector(vi), demonstrating patient preference for OBI.\n\nFDA Also Approved Update to Tuberculosis (TB) Language in U.S. Prescribing\nInformation\nAdditionally, the FDA approved an update to the SKYRIZI prescribing\ninformation's warning and precautions language across all approved\nindications.(iii) The revised label advises healthcare providers to consider\nTB evaluation prior to treatment initiation based on clinical judgment.(iii)\nThis change gives healthcare providers greater flexibility in patient\nassessment before starting SKYRIZI treatment. There is no mandatory TB test\nprior to initiating SKYRIZI.\n\nAbout Crohn's Disease\nCrohn's disease is a chronic, systemic disease that manifests as inflammation\nwithin the gastrointestinal tract, most commonly in the area between the small\nintestine (ileum) and the colon, causing persistent diarrhea and abdominal\npain.(vii,viii) It is a progressive disease, meaning it gets worse over time\nand may lead to life-threatening complications or surgery.(ix,x) Because the\nsigns and symptoms of Crohn's disease are unpredictable, it causes a\nsignificant burden on people living with the disease—not only physically but\nalso emotionally and economically.(xi)\n\nAbout the AFFIRM Study(x)(ii)\nAFFIRM is a global, Phase 3, randomized, placebo-controlled, double-blind\nstudy to evaluate the efficacy and safety of risankizumab subcutaneous (SC) as\nan induction treatment in adult patients with moderately to severely active\nCrohn's disease. Co-primary endpoints were percentage of participants with\nCDAI Clinical Remission (CDAI < 150) and percentage of participants with\nendoscopic response at week 12. A total of 274 patients were randomized in a\n2:1 ratio to risankizumab SC or placebo. Key demographics and baseline\ncharacteristics were generally balanced between the risankizumab SC and\nplacebo groups; 65% had failed advanced therapies for the treatment of CD\nbefore. The study consists of three treatment periods: a placebo-controlled\nPeriod A (baseline to week 12) to evaluate the efficacy and safety of\nrisankizumab SC induction treatment, an extended Period B (week 12 to 24)\nwhere patients receive blinded or open-label treatments based on their\nclinical response at week 12, and a 52-week open-label extension Period C\nwhere all patients receive the approved risankizumab maintenance\ntreatment.(x)(ii) More information on this trial can be found\nat www.clinicaltrials.gov (http://www.clinicaltrials.gov)  (NCT06063967\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4803447-1&h=394422731&u=https%3A%2F%2Fedge.prnewswire.com%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4629860-1%26h%3D4265247759%26u%3Dhttps%253A%252F%252Fclinicaltrials.gov%252Fstudy%252FNCT06063967%253Fterm%253DNCT06063967%2526rank%253D1%26a%3DNCT06063967&a=NCT06063967)\n).(xii)\n\nPatient Access and Support\nAbbVie is committed to helping people access SKYRIZI and other medicines,\nincluding offering a patient support program and co-pay card that may reduce\nout-of-pocket costs to as little as $0 per month for eligible, commercially\ninsured patients. For those with limited or no health insurance, AbbVie offers\nmyAbbVie Assist, a patient assistance program that provides SKYRIZI at no\ncharge to those who qualify. More information about this assistance program\ncan be found at www.AbbVie.com/myAbbVieAssist\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4803447-1&h=3910935453&u=https%3A%2F%2Fedge.prnewswire.com%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4710081-1%26h%3D440661190%26u%3Dhttps%253A%252F%252Fwww.abbvie.com%252FmyAbbVieAssist%26a%3Dwww.AbbVie.com%252FmyAbbVieAssist&a=www.AbbVie.com%2FmyAbbVieAssist)\n.\n\nAbout SKYRIZI(® )(risankizumab-rzaa)\nSKYRIZI is an interleukin-23 (IL-23) inhibitor that blocks IL-23 by\nselectively binding to its p19 subunit. IL-23, a cytokine involved in\ninflammatory processes, is thought to be linked to a number of chronic\nimmune-mediated diseases.(iii) SKYRIZI is approved by the U.S. Food and Drug\nAdministration (FDA) for the treatment of moderately to severely active\nulcerative colitis, plaque psoriasis, psoriatic arthritis and Crohn's\ndisease.(iii)\n\nSKYRIZI(®) (risankizumab-rzaa) U.S. Uses and Important Safety\nInformation(iii\n)SKYRIZI is a prescription medicine used to treat:\n\n * moderate to severe plaque psoriasis in adults and children 6 years of age and\nolder who may benefit from taking injections or pills (systemic therapy) or\ntreatment using ultraviolet or UV light (phototherapy).\n * active psoriatic arthritis in adults and children 6 years of age and older.\n * moderately to severely active Crohn's disease in adults.\n * moderately to severely active ulcerative colitis in adults.\nIMPORTANT SAFETY INFORMATION\n\nWhat is the most important information I should know about\nSKYRIZI(®) (risankizumab-rzaa)?\n\nSKYRIZI is a prescription medicine that may cause serious side effects,\nincluding:\n\nSerious allergic reactions:\n\n * Stop using SKYRIZI and get emergency medical help right away if you get any of\nthe following symptoms of a serious allergic reaction:\n* fainting, dizziness, feeling lightheaded (low blood pressure)\n * swelling of your face, eyelids, lips, mouth, tongue, or throat\n * trouble breathing or throat tightness\n * chest tightness\n * skin rash, hives\n * itching\nInfections:\nSKYRIZI may lower the ability of your immune system to fight infections and\nmay increase your risk of infections. Your healthcare provider may check you\nfor infections and tuberculosis (TB) before starting treatment with SKYRIZI\nand may treat you for TB before you begin treatment with SKYRIZI if you have a\nhistory of TB or have active TB. Your healthcare provider should watch you\nclosely for signs and symptoms of TB during and after treatment with SKYRIZI.\n\n * Tell your healthcare provider right away if you have an infection or have\nsymptoms of an infection, including:\n* fever, sweats, or chills\n * cough\n * shortness of breath\n * blood in your mucus (phlegm)\n * muscle aches\n * warm, red, or painful skin or sores on your body different from your psoriasis\n * weight loss\n * diarrhea or stomach pain\n * burning when you urinate or urinating more often than normal\nDo not use SKYRIZI if you are allergic to risankizumab-rzaa or any of the\ningredients in SKYRIZI. See the Medication Guide or Consumer Brief Summary for\na complete list of ingredients.\n\nBefore using SKYRIZI, tell your healthcare provider about all of your medical\nconditions, including if you:\n\n * have any of the conditions or symptoms listed in the section \"What is the most\nimportant information I should know about SKYRIZI?\"\n * have an infection that does not go away or that keeps coming back.\n * have TB or have been in close contact with someone with TB.\n * have recently received or are scheduled to receive an immunization (vaccine).\nMedications that interact with the immune system may increase your risk of\ngetting an infection after receiving live vaccines. You should avoid receiving\nlive vaccines right before, during, or right after treatment with SKYRIZI.\nTell your healthcare provider that you are taking SKYRIZI before receiving a\nvaccine.\n * are pregnant or plan to become pregnant. It is not known if SKYRIZI can harm\nyour unborn baby.\n * are breastfeeding or plan to breastfeed. It is not known if SKYRIZI passes\ninto your breast milk.\n * become pregnant while taking SKYRIZI. You are encouraged to enroll in the\nPregnancy Registry, which is used to collect information about the health of\nyou and your baby. Talk to your healthcare provider or call 1-877-302-2161 or\nvisit\nhttp://glowpregnancyregistry.com (http://glowpregnancyregistry.com)\nto enroll in this registry.\nTell your healthcare provider about all the medicines you take, including\nprescription and over-the-counter medicines, vitamins, and herbal supplements.\n\nWhat are the possible side effects of SKYRIZI?\n\nSKYRIZI may cause serious side effects. See \"What is the most important\ninformation I should know about SKYRIZI?\"\n\nLiver problems may happen while being treated for Crohn's disease or\nulcerative colitis: A person with Crohn's disease who received SKYRIZI through\na vein in the arm developed changes in liver blood tests with a rash that led\nto hospitalization. Your healthcare provider will do blood tests to check your\nliver before, during, and at least up to 12 weeks of treatment, and may stop\ntreatment with SKYRIZI if you develop liver problems. Tell your healthcare\nprovider right away if you notice any of the following symptoms: unexplained\nrash, nausea, vomiting, stomach (abdominal) pain, tiredness (fatigue), loss of\nappetite, yellowing of the skin and eyes (jaundice), and dark urine.\n\nThe most common side effects of SKYRIZI in people treated for Crohn's disease\nand ulcerative colitis include: upper respiratory infections, headache, joint\npain, stomach (abdominal) pain, injection site reactions, low red blood cells\n(anemia), fever, back pain, urinary tract infection, and rash.\n\nThe most common side effects of SKYRIZI in people treated for plaque psoriasis\nand psoriatic arthritis include: upper respiratory infections, headache,\nfeeling tired, injection site reactions, and fungal skin infections.\n\nThese are not all the possible side effects of SKYRIZI. Call your doctor for\nmedical advice about side effects.\n\nUse SKYRIZI exactly as your healthcare provider tells you to use it.\n\nSKYRIZI (risankizumab-rzaa) is available in a 150 mg/mL prefilled syringe and\npen, a 55 mg/0.37 mL prefilled syringe, a 600 mg/10 mL vial for intravenous\ninfusion, and a 180 mg/1.2 mL or 360 mg/2.4 mL single-dose prefilled cartridge\nwith on-body injector.\n\nYou are encouraged to report negative side effects of prescription drugs to\nthe FDA. Visit www.fda.gov/medwatch\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4803447-1&h=1318714086&u=https%3A%2F%2Fwww.fda.gov%2Fsafety%2Fmedwatch-fda-safety-information-and-adverse-event-reporting-program&a=www.fda.gov%2Fmedwatch)\nor call 1-800-FDA-1088.\n\nIf you are having difficulty paying for your medicine, AbbVie may be able to\nhelp.\n\nVisit AbbVie.com/PatientAccessSupport\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4803447-1&h=2300629693&u=https%3A%2F%2Fwww.abbvie.com%2Fpatientaccesssupport&a=AbbVie.com%2FPatientAccessSupport)\n to learn more.\n\nPlease click here for the Full Prescribing Information\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4803447-1&h=3631654216&u=https%3A%2F%2Fwww.rxabbvie.com%2Fpdf%2Fskyrizi_pi.pdf&a=Full+Prescribing+Information%C2%A0)\nand Medication Guide\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4803447-1&h=1846813211&u=https%3A%2F%2Fwww.rxabbvie.com%2Fpdf%2Fskyrizi_medguide.pdf&a=Medication+Guide)\n.\n\nAbout AbbVie\nAbbVie's mission is to discover and deliver innovative medicines and solutions\nthat solve serious health issues today and address the medical challenges of\ntomorrow. We strive to have a remarkable impact on people's lives across\nseveral key therapeutic areas including immunology, neuroscience and oncology\n– and products and services in our Allergan Aesthetics portfolio. For more\ninformation about AbbVie, please visit us at www.abbvie.com\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4803447-1&h=3066344002&u=http%3A%2F%2Fwww.abbvie.com%2F&a=www.abbvie.com)\n. Follow @abbvie on LinkedIn,\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4803447-1&h=3713524754&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fabbvie%2F&a=LinkedIn%2C)\n Facebook\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4803447-1&h=3161849456&u=https%3A%2F%2Fwww.facebook.com%2FAbbVieGlobal%2F&a=Facebook)\n, Instagram\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4803447-1&h=3763518550&u=https%3A%2F%2Fwww.instagram.com%2Fabbvie%2F&a=Instagram)\n, X\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4803447-1&h=3218184354&u=https%3A%2F%2Ftwitter.com%2Fabbvie&a=X)\n and YouTube.\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4803447-1&h=251236895&u=https%3A%2F%2Fwww.youtube.com%2Fuser%2FAbbVie&a=YouTube.)\n\nAbout AbbVie in Immunology\nAbbVie is relentless in our pursuit to redefine the standard of care for\npatients living with immune-mediated conditions, with the goal of helping them\nlive a life free from the limitations of their disease. For nearly 30 years,\nAbbVie has led and helped shape the field of immunology through groundbreaking\nscience and trusted medicines. Building on deep expertise across\ngastroenterology, rheumatology, dermatology and other areas of high unmet\nneed, we continue to invest in a broad and differentiated pipeline –\nspanning innovative modalities, novel mechanisms of action and next-generation\napproaches designed to conquer the complex biology underlying immune-mediated\ndisease.\n\nToday, more than 1 million patients worldwide are treated with AbbVie's\nimmunology medicines, approved in more than 175 countries across 20+\nimmune-mediated diseases that impact adult and pediatric populations. As we\nwork to strengthen our legacy and drive the next wave of innovation, we remain\nfocused on delivering meaningful progress for patients and expanding access to\nour medicines. For more information, please visit www.abbvie.com/immunology\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4803447-1&h=791845188&u=https%3A%2F%2Fwww.abbvie.com%2Fscience%2Fareas-of-focus%2Fimmunology.html&a=www.abbvie.com%2Fimmunology)\n.\n\nForward-Looking Statements\nSome statements in this news release are, or may be considered,\nforward-looking statements for purposes of the Private Securities Litigation\nReform Act of 1995. The words \"believe,\" \"expect,\" \"anticipate,\" \"project\" and\nsimilar expressions and uses of future or conditional verbs, generally\nidentify forward-looking statements. AbbVie cautions that these\nforward-looking statements are subject to risks and uncertainties that may\ncause actual results to differ materially from those expressed or implied in\nthe forward-looking statements. Such risks and uncertainties include, but are\nnot limited to, challenges to intellectual property, competition from other\nproducts, difficulties inherent in the research and development process,\nadverse litigation or government action, changes to laws and regulations\napplicable to our industry, the impact of global macroeconomic factors, such\nas economic downturns or uncertainty, international conflict, trade disputes\nand tariffs, and other uncertainties and risks associated with global business\noperations. Additional information about the economic, competitive,\ngovernmental, technological and other factors that may affect AbbVie's\noperations is set forth in Item 1A, \"Risk Factors,\" of AbbVie's 2025 Annual\nReport on Form 10-K, which has been filed with the Securities and Exchange\nCommission, as updated by its Quarterly Reports on Form 10-Q and in other\ndocuments that AbbVie subsequently files with the Securities and Exchange\nCommission that update, supplement or supersede such information. AbbVie\nundertakes no obligation, and specifically declines, to release publicly any\nrevisions to forward-looking statements as a result of subsequent events or\ndevelopments, except as required by law.\n U.S. Media:                                                             Investors:\n\nJasmine Farley\nLiz Shea\n\n+1 (847) 309-2779\n+1 (847) 935-2211\n\nJasmine.Farley@abbvie.com (mailto:Jasmine.Farley@abbvie.com)\nLiz.Shea@abbvie.com (mailto:Liz.Shea@abbvie.com)\n\nGlobal Media:\n\nGiovanna Chandler\n\n+1 (571) 867-1967\n\nGiovanna.Chandler@abbvie.com (mailto:Giovanna.Chandler@abbvie.com)\n\nReferences:\ni. Co-primary endpoint defined as Crohn's Disease Activity Index (CDAI) score\n<150.\nii. Co-primary endpoint defined as decrease in SES-CD > 50% from\nbaseline (or for patients with isolated ileal disease and a baseline SES-CD of\n4, at least a 2-point reduction from baseline), as scored by a central\nreviewer.\niii. SKYRIZI [Package Insert]. North Chicago, IL: AbbVie Inc.\niv. Defined as CDAI of 220 to 450 and SES-CD ≥ 6 (or ≥ 4 for isolated\nileal disease).\nv. Keefer L, Griffith JM, Yang M, et al. Treatment satisfaction and patients'\nexperiences with risankizumab on-body injector among adults with Crohn's\ndisease in clinical practice: initial results from the ASPIRE-CD study. Poster\nP5425. Presented at: American College of Gastroenterology Annual Scientific\nMeeting; October 24-29, 2025; Phoenix, AZ.\nvi. Data on file, AbbVie Inc. Source: ZS Associates; December 2024-February\n2025.\nvii. Crohn's & Colitis Foundation. The facts about inflammatory bowel\ndiseases. Crohn's & Colitis Foundation. Published November 2014. Accessed\nOctober 13, 2026.\nhttps://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4803447-1&h=231462167&u=https%3A%2F%2Fwww.crohnscolitisfoundation.org%2Fsites%2Fdefault%2Ffiles%2F2019-02%2FUpdated%2520IBD%2520Factbook.pdf&a=https%3A%2F%2Fwww.crohnscolitisfoundation.org%2Fsites%2Fdefault%2Ffiles%2F2019-02%2FUpdated%2520IBD%2520Factbook.pdf)\n.\nviii. Mayo Clinic. Crohn's disease - Symptoms and causes. Mayo Clinic.\nAccessed February 23, 2026.\nhttps://www.mayoclinic.org/diseases-conditions/crohns-disease/symptoms-causes/syc-20353304\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4803447-1&h=3194509179&u=https%3A%2F%2Fwww.mayoclinic.org%2Fdiseases-conditions%2Fcrohns-disease%2Fsymptoms-causes%2Fsyc-20353304&a=https%3A%2F%2Fwww.mayoclinic.org%2Fdiseases-conditions%2Fcrohns-disease%2Fsymptoms-causes%2Fsyc-20353304)\n.\nix. Mehta F. Report: economic implications of inflammatory bowel disease and\nits management. Am J Manag Care. 2016 Mar;22(3 Suppl):s51-60.\nx. Kaplan G. The global burden of IBD: from 2015 to 2025. Nat Rev\nGastroenterol Hepatol. 2015 Dec;12(12):720-7. doi: 10.1038/nrgastro.2015.150.\nxi. Gajendran M, et al. A comprehensive review and update on Crohn's disease.\nDis Mon. 2018 Feb;64(2):20-57. doi: 10.1016/j.disamonth.2017.07.001.\nxii. ClinicalTrials.gov. A Study to Evaluate Efficacy and Safety of\nRisankizumab Subcutaneous Induction in Participants With Moderately to\nSeverely Active Crohn's Disease (AFFIRM). NCT06063967. Available\nat: https://clinicaltrials.gov/study/NCT06063967\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4803447-1&h=155623405&u=https%3A%2F%2Fedge.prnewswire.com%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4803447-1%26h%3D2888818247%26u%3Dhttps%253A%252F%252Fclinicaltrials.gov%252Fstudy%252FNCT06063967%26a%3Dhttps%253A%252F%252Fclinicaltrials.gov%252Fstudy%252FNCT06063967&a=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT06063967)\n. Accessed October 13, 2026.\n\n \n\nView original\ncontent:https://www.prnewswire.com/news-releases/us-fda-approves-subcutaneous-induction-regimen-for-abbvies-skyrizi-risankizumab-rzaa-for-adults-with-moderately-to-severely-active-crohns-disease-302918434.html\n(https://www.prnewswire.com/news-releases/us-fda-approves-subcutaneous-induction-regimen-for-abbvies-skyrizi-risankizumab-rzaa-for-adults-with-moderately-to-severely-active-crohns-disease-302918434.html)\n\nSOURCE AbbVie\n\n\n\nCopyright (c) 2026 PR Newswire Association,LLC. All Rights Reserved."},"type":"article","timestamp":"2026-10-23T19:33:57.910442332Z","server_sent_at_ms":1792784037910},"received_at":"2026-10-23T19:33:58.082Z","source_url":"https://www.prnewswire.com/news-releases/us-fda-approves-subcutaneous-induction-regimen-for-abbvies-skyrizi-risankizumab-rzaa-for-adults-with-moderately-to-severely-active-crohns-disease-302918434.html"},"analysis":{"id":"166682","press_release_id":"178778","analysis_json":{"industry":{"label":"Pharmaceuticals","sector":"Health Care"},"redFlags":[],"eventType":"fda_approval","narrative":"The FDA approved a subcutaneous induction regimen for AbbVie's SKYRIZI in adults with moderately to severely active Crohn's disease, allowing patients to start treatment at home via an on-body injector.\n\nIn the pivotal Phase 3 AFFIRM trial, SC SKYRIZI beat placebo on both co-primary endpoints at week 12; in advanced therapy-naive patients, 74% achieved clinical remission versus 27% on placebo, with endoscopic response four times placebo (60% vs 15%).\n\nThe FDA also relaxed the label's TB testing language across all SKYRIZI indications, giving physicians clinical-judgment flexibility — a further commercial tailwind for AbbVie's immunology franchise.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"SKYRIZI gains at-home subcutaneous induction with standout naive-patient data, strengthening AbbVie's Crohn's franchise against infusion-based rivals."},"keyFigures":{"drugName":"SKYRIZI (risankizumab-rzaa)","phaseOfTrial":"Phase 3","customDimensions":{"affirm_patients_randomized":274,"clinical_remission_total_placebo":"30%","clinical_remission_total_skyrizi":"56%","clinical_remission_at_naive_placebo":"27%","clinical_remission_at_naive_skyrizi":"74%","endoscopic_response_at_naive_placebo":"15%","endoscopic_response_at_naive_skyrizi":"60%"}},"quotedText":"With the approval of subcutaneous induction, we are building on the strong efficacy of SKYRIZI while giving patients and physicians greater flexibility in how treatment is initiated.","namedEntities":{"people":[{"name":"Roopal Thakkar, M.D.","role":"EVP R&D and Chief Scientific Officer, AbbVie"},{"name":"Millie D. Long, M.D., MPH","role":"lead investigator of AFFIRM, University of North Carolina at Chapel Hill"}],"products":["SKYRIZI","risankizumab-rzaa","SKYRIZI on-body injector (OBI)"],"companies":[{"name":"AbbVie","ticker":"ABBV","relationship":"filer/manufacturer"}],"dollarAmounts":[]},"materialImpact":{"score":3,"reasoning":"FDA approval of a subcutaneous induction regimen plus label update for AbbVie's blockbuster SKYRIZI expands patient convenience and competitive positioning in Crohn's disease. Meaningful commercially, but a label expansion rather than a binary new-drug event for a mega-cap."},"tickerRelevance":{"others":[],"primary":"ABBV"},"globalImportance":45,"audienceRelevance":55,"eventTypeSecondary":["clinical_trial"],"importanceComponents":{"tickerTier":"mega-cap","eventGravity":"label-expansion-approval","noveltyPenalty":"route-of-administration expansion, not new molecule approval","drugFranchiseWeight":"SKYRIZI is a top blockbuster"}},"event_type":"fda_approval","event_type_secondary":["clinical_trial"],"sentiment":"bullish","material_impact_score":3,"narrative":"The FDA approved a subcutaneous induction regimen for AbbVie's SKYRIZI in adults with moderately to severely active Crohn's disease, allowing patients to start treatment at home via an on-body injector.\n\nIn the pivotal Phase 3 AFFIRM trial, SC SKYRIZI beat placebo on both co-primary endpoints at week 12; in advanced therapy-naive patients, 74% achieved clinical remission versus 27% on placebo, with endoscopic response four times placebo (60% vs 15%).\n\nThe FDA also relaxed the label's TB testing language across all SKYRIZI indications, giving physicians clinical-judgment flexibility — a further commercial tailwind for AbbVie's immunology franchise.","key_figures":{"drugName":"SKYRIZI (risankizumab-rzaa)","phaseOfTrial":"Phase 3","customDimensions":{"affirm_patients_randomized":274,"clinical_remission_total_placebo":"30%","clinical_remission_total_skyrizi":"56%","clinical_remission_at_naive_placebo":"27%","clinical_remission_at_naive_skyrizi":"74%","endoscopic_response_at_naive_placebo":"15%","endoscopic_response_at_naive_skyrizi":"60%"}},"named_entities":{"people":[{"name":"Roopal Thakkar, M.D.","role":"EVP R&D and Chief Scientific Officer, AbbVie"},{"name":"Millie D. Long, M.D., MPH","role":"lead investigator of AFFIRM, University of North Carolina at Chapel Hill"}],"products":["SKYRIZI","risankizumab-rzaa","SKYRIZI on-body injector (OBI)"],"companies":[{"name":"AbbVie","ticker":"ABBV","relationship":"filer/manufacturer"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:5c812bd9e28b810d","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-10-23T19:34:03.783Z","global_importance":45,"audience_relevance":55,"importance_components":{"tickerTier":"mega-cap","eventGravity":"label-expansion-approval","noveltyPenalty":"route-of-administration expansion, not new molecule approval","drugFranchiseWeight":"SKYRIZI is a top blockbuster"}},"durationMs":5659,"modelName":"glm-5.3-flashx"}}