On September 11th 2014, Novo Nordisk announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the FDA has completed its meeting regarding the New Drug Application for Saxenda (liraglutide 3 mg). Saxenda is a once-daily human GLP-1 analogue for the treatment of obesity.
The overall benefit-risk assessment for Saxenda was favorable and supports approval for chronic weight management in individuals with a BMI of 30 or greater, or 27 or greater in the presence of at least one weight-related condition.
Saxenda is an investigational product and is not yet approved by the FDA. It is a higher dose of the diabetes drug Victoza. Victoza has been available in the U.S since 2010 for the treatment of type 2 diabetes. Saxenda (liraglutide 3 mg) is a once-per-day glucagon-like peptide-1 (GLP-1) analogue with 97% similarity to naturally occurring human GLP-1, a hormone that is released in response to food intake. In other words: Saxenda regulates appetite and food intake by decreasing hunger and increasing feelings of fullness and satiety after eating.