AbbVie’s Skyrizi Secures Key FDA Approval for Ulcerative Colitis Treatment

1. FDA Approval: The U.S. Food and Drug Administration (FDA) has approved AbbVie's Skyrizi (risankizumab-rzaa) for the treatment of moderately to severely active ulcerative colitis in adults.
2. First IL-23 Inhibitor: Skyrizi is the first IL-23 specific inhibitor approved for both moderate to severe ulcerative colitis and moderate to severe Crohn's disease.
3. Clinical Trials: The approval is based on two Phase 3 clinical trials, INSPIRE and COMMAND, which demonstrated significant improvements in clinical remission and endoscopic improvement compared to placebo.
4. Treatment Regimen: The approved treatment regimen includes a 12-week induction period with three 1200mg doses administered every four weeks, followed by maintenance therapy at either 180mg or 360mg every eight weeks.
5. Impact: This approval expands AbbVie's portfolio across inflammatory bowel disease (IBD) and addresses ongoing needs for patients with ulcerative colitis, a chronic and debilitating condition affecting over 1 million people in the United States.