The Food and Drug Administration (FDA)’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has unanimously voted 16-0 to support the approval of Novo Nordisk’s semaglutide, a selective glucagon-like peptide-1 receptor agonist (GLP-1 RA).
The FDA Committee’s positive recommendation was based on data from the global development program, SUSTAIN, which evaluated the safety and efficacy of once-weekly semaglutide. Over 8,000 adults with type 2 diabetes were evaluated in the Phase 3a clinical trial program that consisted of 8 trials. The study population included type 2 diabetes adults at high cardiovascular risk with or without renal disease. The safety profile of semaglutide was consistent with other GLP-1 RA agents.
Due to its high albumin binding and long half-life, semaglutide is appropriate for once-weekly dosing, which could potentially improve patient adherence. It works by stimulating insulin and suppressing glucagon secretion in a glucose-dependent manner.
Novo Nordisk is seeking approval for semaglutide 0.5mg and 1mg for once-weekly subcutaneous administration, as adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes. While not bound by the Advisory Committee’s recommendation, the FDA takes its guidance into consideration.
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