AbbVie Submits Regulatory Application to EMA for SKYRIZI® (risankizumab) Subcutaneous Induction for Adults with Moderately to Severely Active Crohn's Disease
Rhea-AI Summary
AbbVie (NYSE: ABBV) has submitted a regulatory application to the European Medicines Agency (EMA) for SKYRIZI (risankizumab) subcutaneous (SC) induction to treat adult patients with moderately to severely active Crohn's disease. The filing is supported by positive Phase 3 AFFIRM study data evaluating SC induction efficacy and safety.
SKYRIZI is already approved in the EU for intravenous (IV) induction and SC maintenance in Crohn's disease, as well as for plaque psoriasis, psoriatic arthritis and ulcerative colitis. If approved, Crohn's patients could choose either SC injection or IV infusion for induction, followed by SC maintenance every eight weeks.
Positive
- EMA application submitted for SKYRIZI SC induction in adult Crohn's disease
- Supported by Phase 3 AFFIRM randomized, placebo-controlled trial in 289 patients
- Flexible induction options potential: subcutaneous or intravenous, with SC maintenance every eight weeks
- High-need population targeted: 65% of AFFIRM patients had failed prior advanced therapies
Negative
- None.
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- Submission supported by data from Phase 3 pivotal AFFIRM study
- If approved, adult Crohn's disease patients will have an additional option for induction of risankizumab which is already approved for intravenous (IV) induction
The application to the EMA is supported by the recently shared positive data from the Phase 3 AFFIRM study1 (NCT06063967), which evaluated the efficacy and safety of risankizumab SC as an induction treatment in adult patients with moderately to severely active CD, in those with and without prior advanced therapy failure.
"As treatment goals in Crohn's disease continue to evolve, it is important to provide therapies that can deliver meaningful outcomes from the earliest stages of treatment through long-term disease management," said Roopal Thakkar, M.D., executive vice president, research and development, and chief scientific officer, AbbVie. "This submission builds on the growing body of evidence supporting SKYRIZI and reflects our efforts to advancing treatment approaches that may help patients achieve important clinical and endoscopic outcomes."
In 2022, SKYRIZI became the first specific IL-23 inhibitor approved for the treatment of Crohn's disease in the European Union (EU) to treat adults with moderately to severely active Crohn's disease who have had inadequate response, lost response or were intolerant to conventional or biologic therapy.2 If approved, patients with moderately to severely active CD would have the option to receive their SKYRIZI induction doses via SC injection or through IV infusion and then continue subcutaneous maintenance doses every eight weeks.
About Crohn's Disease
Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal tract, most commonly in the area between the small intestine (ileum) and the colon, causing persistent diarrhea and abdominal pain.3,4 It is a progressive disease, meaning it gets worse over time and may lead to life-threatening complications or surgery.5,6 Because the signs and symptoms of Crohn's disease are unpredictable, it causes a significant burden on people living with the disease—not only physically but also emotionally and economically.7
About the AFFIRM Study1
AFFIRM is a global, Phase 3, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of SC dosing of risankizumab as an induction treatment in adult patients with moderately to severely active Crohn's disease. Co-primary endpoints were achievement of CDAI Clinical Remission (CDAI < 150) and achievement of endoscopic response at week 12. A total of 289 patients were randomized in a 2:1 ratio to risankizumab SC or placebo. Key demographics and baseline characteristics were generally balanced between the risankizumab SC and placebo groups;
About SKYRIZI®
SKYRIZI is an interleukin (IL)-23 inhibitor that selectively blocks IL-23 by binding to its p19 subunit. IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases.2 SKYRIZI is approved by the
EU Indications and Important Safety Information about SKYRIZI® (risankizumab)
Indications2
Skyrizi (risankizumab) is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Skyrizi is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy.
Skyrizi, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).
Skyrizi is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.
Skyrizi is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.
Important Safety Information
Risankizumab is contraindicated in patients hypersensitive to the active substance or to any of the excipients, and in patients with clinically important active infections (e.g. active tuberculosis).
Risankizumab may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, risankizumab should be used with caution.
Treatment with risankizumab should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.
Patients treated with risankizumab should be instructed to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops such an infection or is not responding to standard therapy for the infection, the patient should be closely monitored and risankizumab should not be administered until the infection resolves.
Prior to initiating treatment with risankizumab, patients should be evaluated for tuberculosis (TB) infection. Patients receiving risankizumab should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating risankizumab in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.
Prior to initiating therapy with risankizumab, completion of all appropriate immunizations should be considered according to current immunization guidelines. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with risankizumab. Patients treated with risankizumab should not receive live vaccines during treatment and for at least 21 weeks after treatment.
Serious hypersensitivity reactions, including anaphylaxis, have been reported with use of risankizumab. If a serious hypersensitivity reaction occurs, administration of risankizumab should be discontinued immediately and appropriate therapy initiated.
The most frequently reported adverse reactions were upper respiratory infections (
Commonly (≥ 1/100 to < 1/10) reported adverse reactions included tinea infections, headache, pruritus, rash, eczema, fatigue, and injection site reactions.
This is not a complete summary of all safety information.
See Skyrizi full Summary of Product Characteristics (SmPC) at http://www.ema.europa.eu
Globally, prescribing information varies; refer to the individual country product label for complete information.
About AbbVie in Immunology
AbbVie is relentless in our pursuit to redefine the standard of care for patients living with immune-mediated conditions, with the goal of helping them live a life free from the limitations of their disease. For more than 20 years, AbbVie has led and helped shape the field of immunology through groundbreaking science and trusted medicines. Building on deep expertise across gastroenterology, rheumatology and dermatology, and other areas of high unmet need, we continue to invest in a broad and differentiated pipeline – spanning innovative modalities, novel mechanisms of actions and next-generation approaches designed to conquer the complex biology underlying immune-mediated disease.
Today, more than 1 million patients worldwide are treated with AbbVie's immunology medicines, approved in more than 175 countries across 20+ immune-mediated diseases that impact adult and pediatric populations. As we work to strengthen our legacy and drive the next wave of innovation, we remain focused on delivering meaningful progress for patients and expanding access to our medicines. For more information, please visit www.abbvie.com/immunology.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
References
- AbbVie. Data on file ABVRRTI82775
- SKYRIZI [Summary of Product Characteristics]. AbbVie Deutschland GmbH & Co. KG; [June 2026] available at: https://www.ema.europa.eu/en/documents/product-information/skyrizi-epar-product-information_en.pdf. Accessed July 31, 2026.
- Crohn's & Colitis Foundation. The facts about inflammatory bowel diseases. Crohn's & Colitis Foundation. Published November 2014. Accessed July 31, 2026. https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf
- Mayo Clinic. Crohn's disease - Symptoms and causes. Mayo Clinic. Updated Dec 4, 2025. Accessed July 31, 2026. https://www.mayoclinic.org/diseases-conditions/crohns-disease/symptoms-causes/syc-20353304
- Mehta F. Report: economic implications of inflammatory bowel disease and its management. Am J Manag Care. 2016 Mar;22(3 Suppl):s51-60.
- Kaplan G. The global burden of IBD: from 2015 to 2025. Nat Rev Gastroenterol Hepatol. 2015 Dec;12(12):720-7. doi: 10.1038/nrgastro.2015.150.
- Gajendran M, et al. A comprehensive review and update on Crohn's disease. Dis Mon. 2018 Feb;64(2):20-57. doi: 10.1016/j.disamonth.2017.07.001.
- A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease. (AFFIRM). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT06063967. Accessed July 31, 2026.
- SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc.
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