AbbVie Submits Regulatory Application to EMA for SKYRIZI® (risankizumab) Subcutaneous Induction for Adults with Moderately to Severely Active Crohn's Disease

AbbVie submitted data from its Phase 3 pivotal AFFIRM study to support an additional induction option for adult Crohn’s disease patients using risankizumab (currently approved for IV induction). If approved, patients would gain a new risankizumab induction route (beyond IV), extending use of an already-approved therapy. The news is a positive regulatory/clinical development but details on approval timing and label impact are not provided.