AbbVie Receives FDA Approval for Skyrizi in Crohn's Disease

AbbVie today announced that the FDA has approved Skyrizi (risankizumab-rzaa) for the treatment of adults with moderately to severely active Crohn's disease (CD). In the Phase 3 ADVANCE and MOTIVATE induction trials and the FORTIFY maintenance trial, Skyrizi demonstrated statistically significant improvements in clinical remission, endoscopic response, and endoscopic remission compared to placebo. Skyrizi is an IL-23 inhibitor that selectively targets the p19 subunit of IL-23. This approval expands Skyrizi's use into Crohn's disease, adding to its existing approvals in plaque psoriasis, psoriatic arthritis, and ulcerative colitis.