SignalFDA/Bio
AbbVie Presents New Phase 3 AFFIRM Data Showing Clinical and Endoscopic Outcomes With Subcutaneous SKYRIZI® (risankizumab-rzaa) in Patients With Moderately to Severely Active Crohn's Disease
AbbVie's Phase 3 AFFIRM data show subcutaneous SKYRIZI efficacy in Crohn's disease.
Context
What happened: AbbVie presented Phase 3 AFFIRM data at the American College of Gastroenterology 2026 meeting showing subcutaneous SKYRIZI (risankizumab-rzaa) produced higher endoscopic remission and ulcer-free endoscopy rates versus placebo in adults with moderately to severely active Crohn's disease.
Key numbers: Week 24 endoscopic remission 35.8% SKYRIZI SC vs 9.1% placebo; ulcer-free
Why it matters: The data support AbbVie's application to the U.S. FDA seeking approval of a subcutaneous induction dosing regimen for SKYRIZI, which is also under review with the European Medicines Agency.
Market: +3.3% by next close ($283.48 on Oct 14), +25.7% YTD
What changed
AbbVie presented Phase 3 AFFIRM data at the American College of Gastroenterology 2026 meeting showing subcutaneous SKYRIZI (risankizumab-rzaa) produced higher endoscopic remission and ulcer-free endoscopy rates versus placebo in adults with moderately to severely active Crohn's disease.
Why it matters
The data support AbbVie's application to the U.S. FDA seeking approval of a subcutaneous induction dosing regimen for SKYRIZI, which is also under review with the European Medicines Agency.
Market: +3.3% by next close ($283.48 on Oct 14), +25.7% YTD