AbbVie (NYSE: ABBV) has announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for Skyrizi (risankizumab), marking it for use in treating adults with moderate to severely active ulcerative colitis (UC). This approval positions Skyrizi as the first IL-23 specific inhibitor to be approved for both UC and moderate to severe Crohn’s disease, representing its fourth indication overall.
For the ulcerative colitis indication, the treatment regimen involves three 1,200mg doses of Skyrizi administered every 4 weeks over a 12-week induction period, followed by maintenance therapy with either 180mg or 360mg doses given every 8 weeks. The FDA’s decision was supported by data from two studies: the INSPIRE study, which evaluated Skyrizi as an induction therapy over 12 weeks, and the COMMAND study, which assessed the lower-dosage maintenance regimen over 52 weeks.- Flcube.com
