Novo Nordisk’s Saxenda Gets Nod from FDA Advisory CommitteeBy
Novo Nordisk reports that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the United States Food and Drug Administration (FDA) has recommended for approval the company’s new drug application (NDA) for Saxenda, the intended brand name for liraglutide 3 mg, a once-daily human glucagon-like peptide-1 analog for the treatment of obesity.
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 body mass index of 30 kg/square meters or greater, or 27 kg/square meters or greater in the presence of at least one weight-related comorbidity.
FDA advisory committees are panels of independent experts who advise the FDA on specific questions raised by the FDA as they consider regulatory decisions. Based on the data contained in the NDA for Saxenda, the FDA asked the panel members to discuss whether Novo Nordisk had 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 1.8 mg per day.
The FDA is not bound by the committee's recommendation, but it takes its advice into consideration when reviewing NDAs. The NDA for Saxenda was submitted to the FDA in December 2013. The Prescription Drug User Fee Act (PDUFA) date for completion of the FDA review of the Saxenda NDA is October 20, 2014.
Source: Novo Nordisk