The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) met on October 18th.
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) met on October 18th, to discuss the safety and efficacy of semaglutide injection (NDA 209637) submitted by Novo Nordisk. The proposed indication is to improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise.
The committee first discussed the efficacy and safety of semaglutide, and ultimately was asked for their opinion on whether the data supports approval. Evidence of effectiveness was presented, and it was concluded that semaglutide’s safety was generally consistent with other GLP-1 receptor agonists. Based on the data presented during the meeting, committee members voted 16-0 in favor of the approval of once-weekly semaglutide to improve glycemic control in adults with type 2 diabetes. One member of the committee abstained.
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 clinical development program included eight phase 3 trials consisting of a 2-year cardiovascular outcome trial (CVOT), 5 multi-national trials and 2 trials in Japan. More than 8,000 adults with type 2 diabetes, including adults with high cardiovascular risk profiles, and patients with and without renal disease, participated in SUSTAIN.
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 obligated to follow the advice of the committee, but it takes its guidance into consideration during the final review of data concerning the safety and efficacy of marketed drugs or new drug applications.
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