North Chicago, Illinois, United States, Aug. 27, 2026
AbbVie has submitted a regulatory application to the European Medicines Agency (EMA) seeking approval of SKYRIZI® (risankizumab) subcutaneous (SC) induction for adults with moderately to severely active Crohn’s disease. The application represents a new regulatory step for the established IL-23 inhibitor, which is already approved in the European Union for the treatment of Crohn’s disease. If approved, the new formulation and administration option would provide eligible adult patients with an additional method of receiving their initial SKYRIZI induction doses, alongside the existing intravenous (IV) induction option, before continuing with subcutaneous maintenance dosing every eight weeks. AbbVie said the EMA submission is supported by positive findings from the Phase 3 AFFIRM pivotal study, which evaluated the efficacy and safety of subcutaneous risankizumab as an induction treatment in adults with moderately to severely active Crohn’s disease, including patients with and without previous advanced-therapy failure.
Phase 3 AFFIRM Study Supports EMA Submission
The AFFIRM Phase 3 study was a global, randomized, placebo-controlled, double-blind clinical trial designed to assess the efficacy and safety of subcutaneous risankizumab induction in adults with moderately to severely active Crohn’s disease. The study randomized 289 patients in a 2:1 ratio to receive either risankizumab SC or placebo. Approximately 65% of participants had previously failed advanced therapies for Crohn’s disease, providing an important clinical context for evaluating the investigational induction approach in a population with substantial treatment needs. The study included three treatment periods. The initial placebo-controlled period extended from baseline through week 12 and evaluated the efficacy and safety of subcutaneous risankizumab induction. An extended period from week 12 through week 24 followed, with treatment determined by clinical response, while a 52-week open-label extension allowed participants to receive approved risankizumab maintenance treatment. The study’s co-primary endpoints were achievement of CDAI clinical remission at week 12 and endoscopic response at week 12, providing both clinical and endoscopic measures of treatment activity.
SKYRIZI Targets IL-23 in Crohn’s Disease
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit, a cytokine pathway associated with chronic immune-mediated diseases. AbbVie reported that SKYRIZI became the first specific IL-23 inhibitor approved for Crohn’s disease in the European Union in 2022, for adults with moderately to severely active disease who had inadequate response, lost response or were intolerant to conventional or biologic therapy. The proposed SC induction expansion would potentially allow eligible patients to receive their SKYRIZI induction doses either through subcutaneous injection or intravenous infusion, followed by subcutaneous maintenance treatment every eight weeks. Crohn’s disease is a chronic inflammatory disease affecting the gastrointestinal tract and can cause persistent diarrhea, abdominal pain and progressive intestinal complications. The disease can significantly affect patients’ physical, emotional and economic well-being, while its unpredictable course can make long-term disease management challenging.
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Regulatory Review Could Expand Treatment Flexibility
The EMA submission marks another milestone in AbbVie’s strategy to expand treatment options for patients with immune-mediated gastrointestinal diseases. If the European regulatory authorities approve the application, adult patients with moderately to severely active Crohn’s disease could have greater flexibility in how they receive their initial SKYRIZI treatment. AbbVie is seeking the additional SC induction option based on the Phase 3 clinical evidence generated through AFFIRM, while SKYRIZI already has established indications across several immune-mediated conditions, including plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. The regulatory application also highlights the continued development of treatment approaches designed to support patients from initial induction through longer-term disease management. As the EMA evaluates the submission, the decision will determine whether subcutaneous SKYRIZI induction can become an additional treatment option for eligible adults with moderately to severely active Crohn’s disease in the European Union.
Source: AbbVie press relese
