Officials with Novo Nordisk have announced that the FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 16-0, supporting the approval of once-weekly semaglutide to improve glycemic control in adults with type 2 diabetes.
Officials with Novo Nordisk have announced that the FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) 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 the SUSTAIN clinical trials, which evaluated the safety and efficacy of semaglutide, administered once-weekly. SUSTAIN 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.
The NDA for once-weekly semaglutide was submitted to the FDA in December 2016 under the 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.
"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," Todd Hobbs, vice president and U.S. chief medical officer of Novo Nordisk said in a press release about the vote. "We look forward to continuing to work with the FDA as they complete their review of semaglutide."
For more on diabetes treatment options, view the video below.
Novo Nordisk receives positive 16-0 vote from FDA Advisory Committee in favor of approval for semaglutide [news release]. Plainsboro, NJ. Novo Nordisk website. October 18, 2017. http://press.novonordisk-us.com/2017-10-18-Novo-Nordisk-receives-positive-16-0-vote-from-FDA-Advisory-Committee-in-favor-of-approval-for-semaglutide