Novo Nordisk receives positive 16-0 vote from FDA Advisory Committe
Novo Nordisk announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration voted 16-0, supporting the approval of once-weekly semaglutide to improve glycemic control in adults with type 2 diabetes. One member of the committee abstained. Based on the data contained in the New Drug Application for semaglutide, the FDA asked the panel members to discuss whether Novo Nordisk has provided adequate evidence to demonstrate the efficacy and safety profile of semaglutide for the treatment of type 2 diabetes in adults. The recommendation for approval was based on data from SUSTAIN, a comprehensive global development program that evaluated the safety and efficacy of semaglutide, administered once-weekly. The global SUSTAIN Phase 3a clinical trial program comprised eight clinical trials, involving more than 8,000 adults with type 2 diabetes, including adults with high cardiovascular risk profiles, with and without renal disease.