Novo Nordisk receives positive 16-0 vote from FDA advisory committee in favor of approval for semaglutide.
Novo Nordisk announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S. Food and Drug Administration (FDA) 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 (NDA) 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 (one of which was a 2-year cardiovascular outcomes trial), involving more than 8,000 adults with type 2 diabetes, including adults with high cardiovascular risk profiles, with and without renal disease.
“Semaglutide has the potential to impact the lives of people with type 2 diabetes by helping to meaningfully reduce A1c. This treatment option may also help people lose weight,” said Todd Hobbs, vice president and U.S. chief medical officer of Novo Nordisk. “We look forward to continuing to work with the FDA as they complete their review of semaglutide.”
The NDA for once-weekly semaglutide was submitted to the FDA in December 2016 under the U.S. FDA’s Prescription Drug User Fee Act V (PDUFA V) regulation. Semaglutide is currently also under review by the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency.
About Advisory Committees
FDA advisory committees are panels of independent experts who advise the FDA on specific questions raised by the FDA as they consider regulatory decisions. The FDA is not bound by the committee’s recommendation, but it takes its advice into consideration when reviewing data concerning the safety and efficacy of marketed drugs or new drug applications.
(Source: Novo Nordisk A/S)
