FDA Approves SC Induction With Risankizumab in Crohn's Disease

The U.S. Food and Drug Administration (FDA) approved an subcutaneous (SC) induction regimen with risankizumab for adults with moderate to severe Crohn's disease, the agency announced October 23.

In the Phase 3 AFFIRM trial, which assessed the efficacy and safety of SC risankizumab versus placebo in patients with moderately to severely active Crohn's disease, risankizumab demonstrated superiority in the coprimary endpoints of clinical remission and endoscopic response at week 12. Risankizumab also met secondary endpoints, including endoscopic remission and FACIT fatigue scores, at week 12 vs. placebo.

A total of 274 patients were randomized in a 2:1 ratio to risankizumab SC or placebo. Although the study enrolled a primarily treatment-refractory population, these Phase 3 results were particularly strong with patients advanced therapy-naïve. By week 12, 74% of patients who had not previously received advanced therapy were in clinical remission vs. 27% in the placebo arm. Further, the advanced therapy-naïve patients achieved endoscopic response at 4 times the rate of placebo (60% vs. 15%, respectively). Among patients who had previously lost response or failed to respond to advanced therapy, 45% achieved clinical remission vs 31% in the placebo group, and 33% achieved endoscopic response compared to 15% of the placebo cohort. 

The safety profile of risankizumab for induction was generally consistent with its known profile in Crohn's disease, with no new safety risks observed.

Induction doses for SC risankizumab are delivered by an on-body injector induction pack; patients then continue using an the on-body injector once every 8 weeks throughout the course of maintenance treatment.

U.S. FDA Approves Subcutaneous Induction Regimen for AbbVie's SKYRIZI® (risankizumab-rzaa) for Adults With Moderately to Severely Active Crohn's Disease. Press release. Abbvie. October 23, 2026. https://news.abbvie.com/2026-10-23-U-S-FDA-Approves-Subcutaneous-Induction-Regimen-for-AbbVies-SKYRIZI-R-risankizumab-rzaa-for-Adults-With-Moderately-to-Severely-Active-Crohns-Disease