AbbVie receives EMA Committee positive opinion for Crohn's Disease treatment Risankizumab
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit.
North Chicago: AbbVie has announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CMHP) has 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.
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit.
"We continue to raise the bar in researching treatments for immune-mediated gastroenterological conditions through more stringent and innovative clinical trial design, such as the first time a Phase 3 trial has reported co-primary endpoints, endoscopic response and clinical remission," said Neil Gallagher, M.D., Ph.D., vice president, development, chief medical officer, AbbVie. "With the recent CHMP recommendation for risankizumab in Crohn's disease, we're getting closer toward helping patients find sufficient disease control for this disruptive condition."
AbbVie's application for the approval of risankizumab in Crohn's disease is supported by data from three Phase 3 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.
"Living with Crohn's disease can pose many challenges and significantly impact a patient's health-related quality of life," said Marc Ferrante, M.D., Ph.D., Department of Gastroenterology and Hepatology, University Hospitals Leuven, Belgium. "Risankizumab could be an encouraging option for adult patients that continue to have moderately to severely active Crohn's disease and I look forward to the European Commission's final decision."
Use of risankizumab in Crohn's disease is not approved in the European Union, and its safety and efficacy remain under evaluation.
Risankizumab (SKYRIZI) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal tract, causing persistent diarrhea 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. Because the signs and symptoms of Crohn's disease are unpredictable, it causes a significant burden on people living with the disease—not only physically, but also emotionally and economically.
