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news.Novo Nordisk has announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the Food and Drug Administration (FDA) has completed its meeting regarding the New Drug Application (NDA) for Saxenda, the intended brand name for liraglutide 3 mg, a once-daily human GLP-1 analogue for the treatment of obesity.
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Based on the data contained in the NDA 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 1.8 mg 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 body mass index (BMI) 30 kg/m2 or greater, or 27 kg/m2 or greater in the presence of at least one weight-related comorbidity.
"We are pleased with the clear recommendation from the Advisory Committee," says Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.
"We look forward to working with the FDA as they complete their review of Saxenda. Obesity is a serious public health issue in the U.S. and we are committed to making Saxenda® a new treatment option for adults with obesity."
The recommendation was based on data from clinical trials of Saxenda®, including the phase 3 SCALE clinical trial program, which involved more than 5,000 people who have obesity (BMI =30 kg/m2), or who are overweight (BMI =27 kg/m2) with comorbidities.
The NDA was submitted to the FDA on December 20, 2013. The Prescription Drug User Fee Act (PDUFA) date for completion of the FDA review of the Saxenda NDA is October 20, 2014.
FDA Advisory Committees are panels of independent experts who advise the FDA on specific questions raised by the FDA as they consider regulatory decisions. The FDA is not bound by the Committee’s recommendation, but it takes its advice into consideration when reviewing New Drug Applications.
According to the FDA Amendment Act of 2007 (FDAAA), the FDA should refer drugs to an Advisory Committee meeting, or alternatively justify why an Advisory Committee meeting was not requested.