U.S. FDA Approves SKYRIZI® (risankizumab-rzaa) for Ulcerative Colitis

The U.S. Food and Drug Administration (FDA) has approved SKYRIZI® (risankizumab-rzaa) for the treatment of adults with moderately to severely active ulcerative colitis. This approval is supported by two Phase 3 clinical trials, INSPIRE and COMMAND, which evaluated the efficacy and safety of SKYRIZI®. The INSPIRE study was a 12-week induction study, while the COMMAND study was a 52-week maintenance study. Both studies showed that SKYRIZI® achieved clinical remission, the primary endpoint, along with endoscopic improvement, a key secondary endpoint.

SKYRIZI® is the first IL-23 antagonist approved for both ulcerative colitis and Crohn's disease, expanding AbbVie's portfolio across inflammatory bowel disease (IBD). The drug's dosing for this indication includes a 12-week induction period with three 1200 mg doses delivered every four weeks, followed by maintenance therapy of either 180 mg or 360 mg delivered every eight weeks. Following the induction period, SKYRIZI® treatment can be maintained at home using an on-body injector (OBI), a hands-free device designed for patient convenience.

Ulcerative colitis is a chronic, idiopathic, immune-mediated inflammatory bowel disease that causes continuous mucosal inflammation in the large intestine. It affects over 1 million people in the United States, with symptoms including abdominal pain, bloody stool, and urgency to use the bathroom. The disease can lead to serious complications, including surgery, cancer, or death.

AbbVie is committed to helping patients access SKYRIZI® and other medicines through patient support programs and financial assistance, including the myAbbVie Assist program, which provides the drug at no charge to eligible patients. The approval of SKYRIZI® for ulcerative colitis represents a significant advancement in the treatment of IBD, offering new hope for patients suffering from this debilitating condition.