AbbVie (ABBV) announced that it has filed a regulatory application with the European Medicines Agency (EMA) for SKYRIZI subcutaneous induction in adult patients with moderately to severely active Crohn’s disease.
Crohn’s disease (CD) is a chronic inflammatory condition of the gastrointestinal tract that can cause persistent diarrhea, abdominal pain, and serious complications. Current treatment options often require intravenous (IV) induction, which can be burdensome for patients. AbbVie’s submission seeks to broaden access by providing a subcutaneous (SC) induction option, in addition to the already approved IV regimen.
The application is supported by positive results from the Phase 3 AFFIRM study, which evaluated the efficacy and safety of risankizumab SC induction in adults with Crohn’s disease, including patients who had previously failed advanced therapies. The study met its co‑primary endpoints, demonstrating clinical remission and endoscopic response at week 12, with a safety profile consistent with prior SKYRIZI data.
AbbVie noted that SKYRIZI (risankizumab), an IL‑23 inhibitor, has been approved in the European Union since 2022 as the first targeted IL‑23 therapy for Crohn’s disease. If approved, patients could start treatment with either SC injection or IV infusion, followed by SC maintenance dosing every eight weeks.
This submission highlights AbbVie’s commitment to advancing gastroenterology treatments and expanding patient choice in induction therapy. SKYRIZI is also approved for plaque psoriasis, psoriatic arthritis, and ulcerative colitis, underscoring its role in immune‑mediated conditions.
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