The FDA has expanded its approval of risankizumab (Skyrizi) to include a subcutaneous induction regimen for adults with moderately to severely active Crohn’s disease. Previously, patients had to receive induction intravenously before transitioning to subcutaneous maintenance. The new approval allows patients to begin treatment at home using an on-body injector, offering greater flexibility in how therapy is initiated.
The decision was supported by the Phase 3 AFFIRM trial, which evaluated 289 adults with moderate-to-severe Crohn’s disease. At week 12, patients receiving subcutaneous risankizumab achieved higher rates of clinical remission than those receiving placebo (55% vs. 29.6%). Endoscopic response was also higher (44% vs. 14.3%). Benefits were observed in both patients new to advanced therapies and those with prior biologic intolerance or inadequate response.