AbbVie's new indication for risankizumab approved in China for the treatment of ulcerative colitis.

On January 22nd, AbbVie (ABBV.US) announced that risankizumab (brand name: Xianhuiyue) has been approved for a second indication in China, for the treatment of moderate to severe active ulcerative colitis (UC) in adult patients who have had an inadequate response to conventional therapy or biologic agents, or who are intolerant to them. Risankizumab is an IL-23 inhibitor that selectively blocks IL-23 by binding to the IL-23p19 subunit. IL-23 is a cytokine involved in the inflammatory process and is believed to be associated with many chronic immune-mediated diseases. This new indication was based on positive results from the INSPIRE and COMMAND Phase III clinical trials. The results showed that in the INSPIRE induction therapy trial, risankizumab treatment for 12 weeks significantly increased clinical remission rates compared to placebo (20.3% vs 6.2%; adjusted between-group difference 14.0% [95% CI: 10.0%-18.0%]; P<0.001); in the COMMAND maintenance therapy trial, both maintenance doses of 180mg and 360mg for 52 weeks had significantly higher rates of clinical remission compared to the placebo group (40.2% vs 37.6% vs 25.1%). On March 10, 2025, risankizumab was first approved for marketing in China and is indicated for the treatment of moderate to severe active Crohn's disease in adult patients who have had an inadequate response to conventional therapy or biologic agents, or who are intolerant to them.