The US Food and Drug Administration has published briefing documents on Danish insulin giant Novo Nordisk’s (NOV: N) Saxenda (liraglutide) for the treatment of obesity ahead of its Advisory Committee Meeting on September 11.
The documents, made up of submissions from Novo Nordisk and the FDA, will form the basis for the Advisory Committee’s discussion, and give an overview of the clinical and non-clinical data for Saxenda in the management of obesity as an adjunct to diet and physical activity.
Saxenda is a once-daily glucagon-like peptide-1 analogue with 97% similarity to naturally-occurring human GLP-1, a hormone released in response to food intake. It is an investigational product and is not approved by the FDA or European Medicines Agency.
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