FDA Approves Subcutaneous SKYRIZI for Crohn's Disease Induction, Allowing At-Home Treatment

The U.S. Food and Drug Administration (FDA) has approved a subcutaneous induction regimen for AbbVie's SKYRIZI (risankizumab) for Crohn's disease, providing patients with the option to initiate treatment at home rather than requiring an intravenous infusion in a clinical setting. This approval is based on Phase 3 AFFIRM trial data showing 74% of biologic-naive patients achieved clinical remission at week 12 with subcutaneous risankizumab.