Cure8 news brief
If approved, a subcutaneous induction option for risankizumab would let eligible adults start and continue treatment without needing an infusion visit, which can be more convenient and reduce infusion-related costs and scheduling barriers.
Adults with Crohn’s disease who are candidates for risankizumab, patients on or considering biologic therapy, gastroenterologists and infusion-service managers, and payers/formulary decision-makers.
AbbVie has submitted an application to the European Medicines Agency to add a subcutaneous (SC) induction option for risankizumab (SKYRIZI) in adults with moderately to severely active Crohn’s disease, based on Phase 3 AFFIRM data showing a 55% vs 30% week-12 clinical remission difference versus placebo.
The company’s current EU label already includes IV induction with SC maintenance; approval of SC induction would allow patients to avoid infusion centers entirely. AFFIRM randomized 289 patients (2:1) and included many with prior advanced-therapy failure.
The trial also has a 52-week open-label extension, so longer-term durability data are expected to be part of the regulatory package. The EMA’s Day 70 list will indicate whether the agency requires additional information before deciding.
This submission appears driven both by clinical convenience for patients and by marketplace pressure after a competitor secured dual IV and SC induction options. If approved, SC induction could reduce the need for IV infusions at treatment start and shift some costs and logistics away from infusion services.
The article summarizes a press-release–based regulatory submission and cites AFFIRM week-12 remission and endoscopic response results; it does not present full trial data or EMA review outcomes. Final approval depends on the EMA review process (including any Day 70 questions) and is not guaranteed.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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A new FDA approval means another biologic option for people with moderately to severely active Crohn’s disease, including patients who have failed or not tolerated prior therapies.
