AbbVie Seeks EU Nod for Subcutaneous Skyrizi in Crohn's Disease

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AbbVie (ABBV) submitted a regulatory application to the European Medicines Agency for SKYRIZI subcutaneous induction in Crohn's disease. The application is based on positive Phase 3 AFFIRM study results, showing clinical remission and endoscopic response at week 12. If approved, patients could choose between SC injection or IV infusion for induction, followed by SC maintenance dosing. SKYRIZI is already approved for Crohn's disease, plaque psoriasis, psoriatic arthritis, and ulcerative colitis.

AbbVie (ABBV) submitted an application to the EMA for approval of SKYRIZI® (risankizumab) subcutaneous induction for treating adults with moderately to severely active Crohn's disease. The application is supported by positive Phase 3 AFFIRM study data. If approved, it will provide an additional treatment option for patients.