Novo Nordisk A/S's Liraglutide Safe, Effective For Obesity: FDA Panel

September 12, 2014

By Krystle Vermes, BioSpace.com Breaking News Staff

Novo Nordisk A/S announced on Sept. 11 that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration had given its weight loss drug Saxenda a positive 14-1 vote in favor of approval.

Saxenda, which is the brand name for liraglutide, is geared toward the treatment of obesity. The New Drug Application for Saxenda was submitted to the FDA on December 20, 2013.

"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 vote came after the release of data from clinical trials of Saxenda, including a Phase 3 SCALE clinical trial program. More than 5,000 people who were considered obese or overweight participated in the trial.

The 14-1 vote came after the overall benefit-to-risk assessment of the drug was deemed favorable.

Members of the panel were asked to determine whether Novo Nordisk had provided them with enough evidence to determine an efficacy and safety profile for chronic weight management. Panel members were also asked to discuss the safety of Saxenda for chronic weight management depending on the clinical trial and post-marketing experience with liraglutide for diabetes mellitus with doses up to 1.8 mg per day.

Approximately 35 percent of adults in the U.S. are living with obesity, which translates into around 100 million people. Obesity is associated with conditions such as type 2 diabetes, heart disease, sleep apnea and certain types of cancer. It can also reduce life expectancy, and it is influenced by genetic, environmental, physiological and psychological factors.

Saxenda is a once-a-day glucagon-like peptide-1 analogue, which is 97 percent similar to naturally occurring GLP-1, a hormone that is released in the body as a result of food intake. However, Saxenda differs from GLP-1 by regulating appetite and good intake by decreasing hunger and simulating the feeling of fullness after eating.

Novo Nordisk, which is based in Denmark, has more than 90 years of experience in diabetes care. It has 40,700 employees in 75 companies around the world.