FDA advisory committee recommends once-weekly semaglutide for type 2 diabetes. - Novo Nordisk.
Novo Nordisk announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the FDA voted 16-0 in favour of the approval of once-weekly semaglutide to improve glycaemic control in adults with type 2 diabetes. One member of the committee abstained. Based on the data included in the New Drug Application (NDA) for semaglutide, the FDA asked the panel members to discuss whether Novo Nordisk has provided adequate evidence to establish the efficacy and safety profile of semaglutide for the treatment of type 2 diabetes in adults.
The recommendation for approval was based on a global development programme involving more than 8,000 adults with type 2 diabetes in the eight SUSTAIN phase IIIa clinical trials, including a cardiovascular outcomes trial.
Comment: Semaglutide was filed at EMA in December 2016 and the drug is also pending approval in Japan. Novo Nordisk is developing an oral formulation �currently in Phase III study � which could be a competitive advantage if it succeeds.
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