The FDA has approved Novo Nordisk’s weight management drug Saxenda as an adjunct to a low-calorie diet and exercise.

Saxenda (liraglutide [rDNA origin] injection) is indicated for adults with a body mass index over 27 and who have one weight-related complication, including elevated cholesterol, high blood pressure or type 2 diabetes.

The agency’s Dec. 23 approval was based on clinical trials of roughly 4,800 patients in which subjects taking Saxenda were able to lose more of their body weight than those on placebo. The drug’s active ingredient liraglutide mimics a hormone that is released to control hunger when a person eats.

The drug joins several other glucagon peptide-1 receptor agonists, including Novo Nordisk’s Victoza, but should not be used in combination with any of these, the FDA says. As of February, Victoza (liraglutide [rDNA origin] injection) was the leading weight-loss drug on the market, with two-thirds of all sales.

Saxenda carries a boxed warning for thyroid tumors. — Lena Freund