The U.S. Food and Drug Administration approves a new subcutaneous induction regimen for AbbVie’s Skyrizi (risankizumab-rzaa), expanding how the drug can be given to adults with moderately to severely active Crohn’s disease. The approval covers an induction approach delivered via a subcutaneous route.
Context from the sources highlights that the subcutaneous regimen is designed to support early symptom control and endoscopic disease control during treatment, using an on-body injector (OBI) device. PR Newswire says the approval is supported by results from the pivotal Phase 3 AFFIRM study, describing subcutaneous Skyrizi as achieving superior clinical outcomes in that trial. Investing.com focuses on the regulatory approval itself, while PR Newswire adds more detail on the route, the delivery device, and trial framing.
