FDA advisory votes to approve Novo Nordisk diabetes drug for obesity

There was good news for Danish diabetes care giant Novo Nordisk (NOV: N) yesterday, when the US Food and drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) panelists voted in favor of approving the company’s liraglutide – intended trade name Saxenda - for the treatment of obesity.

Based on the data contained in the New Drug Application for Saxenda, the FDA asked the panel members to discuss whether Novo Nordisk has provided adequate evidence to establish the efficacy and safety profile of Saxenda for chronic weight management. Furthermore, the panel members were asked to discuss the safety database for Saxenda for chronic weight management, given the extent of clinical trial and post-marketing experience with liraglutide for diabetes mellitus with doses up to 1.8mg per day.

The panel members voted 14-1 that the overall benefit-risk assessment Saxenda was favorable and supports approval for chronic weight management in individuals with a BMI 30kg/m2 or greater, or 27kg/m2 or greater in the presence of at least one weight-related co-morbidity.

In the Phase IIII SCALE study supporting the NDA for Saxenda, half of obese patients given a daily 3mg injection lost at least 5% of body weight, while 22% lost more than 10%. The drug is proposed for use in patients who also have at least one other weight-related condition, such as hypertension.