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Novo Nordisk FDA submission for semaglutide

Novo Nordisk

Novo Nordisk has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) and a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for semaglutide, a new glucagon-like peptide-1 (GLP-1) analogue administered once-weekly, for the treatment of adults with Type 2 diabetes. Semaglutide is a new once-weekly analogue of human GLP-1 that stimulates insulin and suppresses glucagon secretion in a glucose-dependent manner while decreasing appetite and food intake. Novo Nordisk intends to make once-weekly semaglutide available in a prefilled delivery device based on the same technology platform as FlexTouch.

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