Novo Nordisk’s Weight Loss Drug Saxenda Gets FDA Panel Recommendation

September 18, 2014

An FDA advisory panel last week overwhelmingly recommended approval of Novo Nordisk’s latest weight-loss drug Saxenda.

Members of the agency’s Endocrinologic and Metabolic Drugs Advisory Committee voted 14-1 support approval of Saxenda (liraglutide 3 mg) as an adjunct to diet and exercise in adults with a BMI of 30 or more, or 27 or more with at least one weight-related comorbidity.

The positive recommendation was based on results from the company’s Phase IIIa trial of 5,000 overweight adults, as well as data from Novo Nordisk’s other liraglutide product, Victoza (liraglutide 1.8 mg), which was approved in 2010.

As of February, Victoza was the leading weight-loss drug on the market, with two-thirds of all sales.

While Victoza is indicated for controlling blood sugar in patients with type II diabetes, further analyses of liraglutide showed that the higher dose is required to induce clinically meaningful weight loss, Novo Nordisk spokeswoman Sharon Corbitt said. Liraglutide is a GLP-1 agonist that mimics a hormone that is released to control hunger when a person eats.

Other manufacturers are eyeing the GLP-1 drug market, which was roughly $3 billion worldwide and could grow soon to $5 billion, according to ISI Group estimates in February. Eli Lilly and Boehringer Ingelheim earlier this year submitted their dulaglutide drug, which has shown to be equal to Victoza in Phase III trials. That drug is still under FDA review.

Meanwhile, the FDA last week approved Takeda and Orexigen’s Contrave (extended-release naltrexone HCl and bupropion HCl) for the same indication that Novo Nordisk is seeking in Saxenda. Contrave was the first weight-loss drug to gain FDA approval since Vivus’ Qsymia (phentermine/topiramate) and Arena Pharmaceutical’s Belviq (lorcaserin HCl) were cleared in 2012.

The FDA doesn’t have to follow the recommendation of its advisory panels, but usually does. Saxenda’s PDUFA data is October 20. — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.