AbbVie Wins FDA Approval for Subcutaneous SKYRIZI Induction in Crohn's Disease

AbbVie (ABBV) said the U.S. Food and Drug Administration approved a subcutaneous induction regimen for SKYRIZI (risankizumab-rzaa) in adults with moderately to severely active Crohn's disease, allowing patients to begin treatment at home. The approval is supported by positive results from the Phase 3 AFFIRM trial, which met its co-primary endpoints by demonstrating superiority over placebo in clinical remission and endoscopic response at Week 12. The subcutaneous induction schedule consists of 720 mg administered at Weeks 0, 2, 4 and 8 via an on-body injector, followed by maintenance dosing every eight weeks. Patients may alternatively use the previously approved intravenous induction regimen of 600 mg at Weeks 0, 4 and 8. The FDA also updated SKYRIZI's prescribing information across all approved indications, removing the requirement for mandatory tuberculosis testing before treatment initiation and advising physicians to consider TB evaluation based on clinical judgment. ABBV closed Friday's regular trading at $285.64, up $0.45 or 0.16%.