CHMP positive recommendation for Skyrizi (risankizumab) to treat ulcerative colitis .- AbbVie
The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has granted AbbVie’s ulcerative colitis (UC) drug Skyrizi (risankizumab) a positive recommendation for approval
The committee’s recommendation was based on results from two Phase III studies. In the INSPIRE trial (NCT03398148), 20.3% of patients in the Skyrizi treatment group achieved clinical remission, compared to 6.2% in the placebo group. Furthermore, in the Phase III COMMAND study (NCT03398135), 51% of patients treated with Skyrizi 180 mg and 48% of patients treated with Skyrizi 360mg demonstrated endoscopic improvement in week 52. Skyrizi is a monoclonal antibody therapy that inhibits interleukin-23 (IL-23). This reduces anti-inflammatory processes.
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