FDA Committee Supports Semaglutide Approval for Type 2 Diabetes

The SUSTAIN Phase 3a clinical trial program comprised eight clinical trials, involving more than 8,000 adults
The SUSTAIN Phase 3a clinical trial program comprised eight clinical trials, involving more than 8,000 adults

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. 

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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.

For more information call (800) 727-6500 or visit NovoNordisk-us.com.