FDA Approves AbbVie SKYRIZI Subcutaneous Induction Regimen for Moderately to Severely Active Crohn's Disease in Adults

AbbVie announced that on October 23, 2026, the FDA approved a SKYRIZI (risankizumab-rzaa) subcutaneous induction regimen for adults with moderately to severely active Crohn's disease, allowing administration at home via an on-body injector. The regimen delivers 720 mg at weeks 0, 2, 4 and 8, followed by maintenance every 8 weeks from week 12; intravenous induction remains available. In the Phase 3 AFFIRM study (289 patients), week-12 clinical remission was 56% for SKYRIZI versus 30% for placebo, and endoscopic response was 43% versus 15%, both P<0.001.