FDA approves subcutaneous Skyrizi induction for Crohn’s disease

The U.S. Food and Drug Administration (FDA) has approved a subcutaneous induction regimen for Skyrizi (risankizumab-rzaa) to treat adults with moderately to severely active Crohn’s disease. This approval allows patients to begin their treatment at home using an on-body injector, eliminating the necessity for an initial clinical intravenous infusion.

The decision is based on results from the Phase 3 AFFIRM trial, a global, randomized, double-blind study. At week 12, 56% of patients receiving Skyrizi achieved clinical remission compared to 30% in the placebo group. The study also showed significant improvements in endoscopic response rates.

The subcutaneous induction schedule involves 720 mg administered at weeks 0, 2, 4, and 8, followed by maintenance doses every eight weeks. Patients may still opt for the previously approved intravenous induction method. Additionally, the FDA approved updated prescribing information that advises physicians to consider tuberculosis evaluation based on clinical judgment rather than requiring mandatory testing before starting treatment.