EU approves Skyrizi for Crohn's disease
AbbVie announced the European Commission (EC) approved Skyrizi (risankizumab, 600 mg intravenous [IV] induction and 360 mg subcutaneous [SC] maintenance therapy) as the first specific interleukin-23 (IL-23) inhibitor 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
The EC approval for Skyrizi in Crohn's disease is supported by results from the global Phase III program, which included three studies: ADVANCE induction, MOTIVATE induction and FORTIFY maintenance. The three Phase III studies are multicenter, randomized, double-blind, placebo-controlled studies and include assessments of efficacy, safety and tolerability of Skyrizi. In the ADVANCE and MOTIVATE induction trials, a significantly greater proportion of patients treated with Skyrizi 600 mg IV achieved the co-primary endpoints of clinical remission (per SF/AP) and endoscopic response. In ADVANCE and MOTIVATE, 43% and 35% of patients treated with Skyrizi 600 mg IV achieved clinical remission at week 12, respectively, compared to 22% and 19% of patients receiving placebo. Additionally, 40% and 29% of Skyrizi treated patients achieved endoscopic response at week 12 compared to 12% and 11% of patients receiving placebo.
In the FORTIFY maintenance trial, a significantly greater proportion of patients treated with Skyrizi 360 mg SC achieved the co-primary endpoints of clinical remission (per SF/AP) and endoscopic response. In FORTIFY, 52% of patients treated with Skyrizi 360 mg SC achieved clinical remission at week 52 compared to 40% of patients receiving placebo. Additionally, 47% of patients treated with Skyrizi achieved endoscopic response at week 52 compared to 22% of patients receiving placebo. Additionally, across all three studies, safety results of Skyrizi in Crohn's disease were consistent with the known safety profile of Skyrizi, with no new safety risks observed.
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