Positive CHMP opinion for Skyrizi for the treatment of adults with moderate to severe Crohn's disease
AbbVie announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CMHP) adopted a positive opinion recommending the approval of risankizumab (Skyrizi, 600 mg intravenous [IV] induction and 360 mg subcutaneous [SC] maintenance therapy) for the treatment of adults with moderately to severely active Crohn's disease who have had inadequate response, lost response or were intolerant to conventional or biologic therapy
AbbVie's application for the approval of risankizumab in Crohn's disease is supported by data from three Phase III clinical trials — ADVANCE, MOTIVATE (induction studies) and FORTIFY (maintenance study). Across all three studies, significantly more patients treated with risankizumab achieved the co-primary endpoints of endoscopic response and clinical remission. This includes statistically significant improvements in these endpoints at week 12 compared to placebo with 600 mg intravenous infusions for the ADVANCE and MOTIVATE induction studies. Additionally, a significantly greater proportion of patients treated with risankizumab 360 mg subcutaneous injections achieved endoscopic response and clinical remission at 52 weeks compared to placebo (patients treated with placebo after risankizumab induction) in the FORTIFY maintenance study. Safety results of risankizumab in Crohn's disease were consistent with the known safety profile of risankizumab, with no new safety risks observed.
Risankizumab (Skyrizi) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
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