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AbbVie’s Skyrizi receives EC approval for active Crohn's disease

The approval makes Skyrizi the first specific IL-23 inhibitor as a Crohn's treatment in the EU


AbbVie’s Skyrizi (risankizumab) has been approved by the European Commission (EC) 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 company’s application was supported by results from a global phase 3 programme including three multicentre, randomised, double-blind, placebo controlled studies assessing the efficacy, safety and tolerability of Skyrizi: ADVANCE induction, MOTIVATE induction and FORTIFY maintenance.

In the ADVANCE and MOTIVATE induction trials, a significantly greater proportion of patients treated with a 600mg intravenous dose of Skyrizi achieved the co-primary endpoints of clinical remission and endoscopic response, versus placebo.

43% and 35% of Skyrizi-treated patients achieved clinical remission at week 12, respectively, compared to 22% and 19% of patients receiving placebo. Additionally, 40% and 29% of patients in the treatment group achieved endoscopic response at week 12 compared to 12% and 11% of patients receiving placebo.

Similar results were seen in the FORTIFY maintenance trial, with 52% of patients treated with a 360mg subcutaneous maintenance dose achieving clinical remission at week 52 compared to 40% of patients receiving placebo, and 47% of Skyrizi-treated patients achieving endoscopic response at week 52 compared to 22% in the placebo group.

The induction studies also showed a significant increase in mucosal healing and endoscopic remission. Mucosal healing and endoscopic remission were also observed during the FORTIFY maintenance trial.

Across all three studies, safety results of Skyrizi in Crohn's disease were consistent with its known safety profile, the company reported, with no new safety risks observed.

Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal tract, causing persistent diarrhoea and abdominal pain. It is a progressive disease, meaning it gets worse over time in a substantial proportion of patients or may develop complications that require urgent medical care, including surgery.

"Beyond managing daily symptoms, clinical remission and endoscopic goals are key treatment targets in Crohn's disease," said Marc Ferrante, Department of Gastroenterology and Hepatology, University Hospitals Leuven, Belgium.

He continued: "Research advancements have made it possible for patients to aim for higher treatment goals, including mucosal healing. The approval of Skyrizi as the first IL-23 inhibitor for moderate-to-severe Crohn's disease is a critical step forward towards a treatment option that can support a patient's health goals."

Article by
Emily Kimber

23rd November 2022

From: Research, Regulatory



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