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FDA Advisors Give ‘Thumbs Up’ to Liraglutide (Saxenda) for Treatment of Obesity
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has completed its meeting regarding the new drug application (NDA) for liraglutide (Saxenda), a once-daily human glucagon-like peptide-1 (GLP-1) analogue for the treatment of obesity.
Based on the data in the NDA, the FDA had asked the panel members to discuss whether the product’s developer (Novo Nordisk) had provided adequate evidence to establish the efficacy and safety profile of liraglutide for chronic weight management. Further, the panel members were asked to discuss the safety database for liraglutide for chronic weight management, given the extent of clinical trial and post-marketing experience with liraglutide for diabetes mellitus with doses of up to 1.8 mg per day.
The panel members voted 14 to 1 that the overall benefit–risk assessment of liraglutide was favorable and supported approval of the drug for chronic weight management in individuals with a body mass index (BMI) of 30 kg/m2 or greater, or 27 kg/m2 or greater in the presence of at least one weight-related co-morbidity.
The recommendation was based on data from clinical studies of liraglutide, including the phase III SCALE clinical trial program, which involved more than 5,000 people with obesity (BMI ≥ 30 kg/m2), or who were overweight (BMI ≥ 27 kg/m2) with co-morbidities.
The NDA for Saxenda (liraglutide 3 mg) was submitted to the FDA in December 2013. The Prescription Drug User Fee Act (PDUFA) date for completion of the FDA review is October 20, 2014.
Liraglutide is a once-daily GLP-1 analogue with 97% similarity to naturally occurring human GLP-1, a hormone that is released in response to food intake. Like human GLP-1, liraglutide regulates appetite and food intake by decreasing hunger and by increasing feelings of fullness and satiety after eating.
Liraglutide is already approved for the treatment of diabetes under the brand name Victoza (Novo Nordisk).