FDA Approves Novo Nordisk A/S's Weight Management Drug Saxenda
Published: Dec 29, 2014
December 24, 2014
By Krystle Vermes, BioSpace.com Breaking News Staff
Novo Nordisk announced on Dec. 23 that the U.S. Food and Drug Administration had approved its New Drug Application for Saxenda, also known as liraglutide. It is the first once-a-day glucagon-like peptide-1 analog for the treatment of obesity.
Saxenda is poised to compete against Qsymia, Belviq and Contrave, which are similar rival drugs designed for the treatment of obesity in adults. The drug will carry a label that warns of thyroid tumors, which were observed in trials including rodents. It is unknown whether Saxenda results in similar tumors in humans.
The drug is expected to bring in approximately $566 million in sales by 2017, according to an analysis by Bloomberg.
A Positive Vote
In September, Novo Nordisk announced that the Endrocrinologic and Metabolic Drugs Advisory Committee of the FDA had completed its meeting regarding the NDA for Saxenda. The panel members voted 13-1 that the overall benefit-risk assessment of the drug was favorable. This vote also indicates that they approve of the drug for chronic weight management in adults with a BMI of 30 or higher.
“We are pleased with the clear recommendation from the advisory committee,” said 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 Approval of Contrave
Around the same time that Novo Nordisk made its announcement in September, the FDA announced that it had approved of Contrave, also known as naltrexone hydrochloride and bupropion hydrochloride, for weight management in adults.
“Obesity continues to be a major public health concern,” said Jean-Marc Guettier, director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “When used as directed in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, Contrave provides another treatment option for chronic weight management for people who are obese or are overweight and have at least one weight-related health condition.”
Contrave is also approved for individuals who have a BMI of 30 or higher. The Centers for Disease Control and Prevention estimates that more than one-third of adults in the U.S. are obese.