AbbVie Seeks EMA Approval for Subcutaneous Risankizumab in Crohn's Disease Treatment

AbbVie Submits EMA Application for Risankizumab

AbbVie (NYSE: ABBV), based in North Chicago, Illinois, announced on August 27, 2026, that it has submitted an application to the European Medicines Agency (EMA) for the approval of subcutaneous induction therapy using risankizumab in adults with moderately to severely active Crohn's disease. This application is supported by favorable data from the Phase 3 AFFIRM trial (NCT06063967), which evaluated the efficacy and safety of subcutaneous risankizumab induction therapy in this patient population, regardless of prior treatment history.

The Importance of Treatment in Crohn’s Disease

The treatment goals for Crohn’s disease are constantly evolving, highlighting the need for effective therapies that provide significant outcomes for patients early in their treatment process and throughout long-term disease management. According to Dr. Roopal Thakkar, AbbVie’s Executive Vice President and Chief Scientific Officer, this application reflects the accumulation of evidence related to risankizumab and demonstrates the company’s commitment to developing treatment options aimed at achieving important clinical and endoscopic improvements.

Risankizumab was initially approved in the European Union in 2022 as the first selective IL-23 inhibitor targeting adults with moderately to severely active Crohn's disease who have not responded adequately, experienced decreased effectiveness, or were intolerant to conventional therapies and biologics. If the EMA approves this application, adults with moderately to severely active Crohn's disease will have the choice between subcutaneous and intravenous induction therapy with risankizumab, followed by maintenance therapy every eight weeks with subcutaneous injections.

What is Crohn's Disease?

Crohn's disease is a chronic systemic condition characterized by inflammation of the gastrointestinal tract, leading to persistent diarrhea and abdominal pain. Due to its progressive nature, the disease tends to worsen over time for many patients, potentially causing complications that require urgent interventions such as surgery. The unpredictable nature of Crohn's disease signs and symptoms places significant psychological and financial burdens on patients, in addition to physical challenges.

Insights from the AFFIRM Trial

The AFFIRM trial, a randomized, placebo-controlled, double-blind international study, aimed to assess the efficacy and safety of subcutaneous risankizumab as an induction therapy in adults with moderately to severely active Crohn's disease. The primary endpoints included achieving clinical remission based on the Crohn's Disease Activity Index (CDAI) scores under 150 and demonstrating endoscopic improvement at the 12-week mark. A total of 289 patients were randomly assigned in a 2:1 ratio to receive either subcutaneous risankizumab or a placebo, with baseline characteristics generally balanced across both groups. Notably, 65% of participants had a history of inadequate responses to advanced treatment options for their Crohn's disease.

The study consisted of three distinct treatment periods: a placebo-controlled period A (from baseline to 12 weeks), a blinded or unblinded continuation period B (from 12 weeks to 24 weeks) based on clinical improvement after 12 weeks, and a non-blinded continuation period C of 52 weeks during which all patients received the approved risankizumab maintenance therapy.

For more details on the trial, visit ClinicalTrials.gov.

Understanding Risankizumab

Risankizumab is an IL-23 inhibitor that selectively binds to the p19 subunit of IL-23, blocking its action. IL-23 is believed to play a significant role in various chronic immune-mediated diseases due to its involvement in the inflammatory process. Risankizumab is not only approved for the treatment of Crohn's disease but also for conditions like psoriasis, psoriatic arthritis, and adult ulcerative colitis, making it a versatile option in immunology.

AbbVie’s Commitment to Immunology

AbbVie is committed to addressing the significant limitations imposed by immune-mediated inflammatory diseases on everyday living. Over the past two decades, the company has advanced the field of immunology through pioneering scientific research and the reliable provision of effective medications. AbbVie continues to invest in a diverse and differentiated pipeline, providing innovative therapies designed to overcome the complexities of chronic immune-mediated illnesses.

Currently, AbbVie’s immunology products have been approved in over 175 countries for the treatment of more than 20 immune-mediated inflammatory diseases in both adult and pediatric patients, benefiting over one million patients worldwide. As AbbVie continues to drive the future of innovation, the company is dedicated to delivering meaningful advancements for patients while expanding access to its medications.

For further information on AbbVie’s mission and product offerings, visit AbbVie.com. Follow us on LinkedIn, Facebook, Instagram, X, and YouTube for updates.