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AbbVie’s Skyrizi Checks One Last Box With Phase III Success In Ulcerative Colitis

UC Is Final Planned Indication For IL-23 Inhibitor

 
• By Mandy Jackson

Already approved in Crohn’s disease, Skyrizi now has positive Phase III results in ulcerative colitis with more data expected this year in UC as the field grows more crowded with anti-IL-23 options.

Check marks on four wooden blocks
Ulcerative colitis is the fourth and final indication for Skyrizi • Source: Shutterstock

AbbVie Inc.’s IL-23 inhibitor Skyrizi (risankizumab) delivered its first set of positive Phase III results in ulcerative colitis (UC) on 23 March from INSPIRE, a 12-week induction study, and the company plans to report data from Phase III COMMAND clinical trial, a 52-week maintenance study, during the first half of 2023. Positive results from both trials will position the product for regulatory filings later this year and a launch in UC – an increasingly crowded market, particularly for IL-23 inhibitors – in 2024.

Skyrizi already is approved in the US, EU and several other markets for Crohn’s disease, giving the product a foothold in the inflammatory bowel disease (IBD) market, where Johnson & Johnson’s blockbuster IL-12/IL-23 inhibitor Stelara (ustekinumab) already has major market share in both UC and Crohn’s. (Also see "AbbVie's Skyrizi Adds Crohn's Disease Indication In Europe" - Scrip, 23 November, 2022

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