FDA Clears Semaglutide for Weight Loss When Used With Diet, Exercise

This story has been corrected to note the indications for semaglutide.

The FDA Friday approved semaglutide as a weight management drug in adults with certain comorbidities when used in conjunction with a reduced calorie diet and increased physical activity.

It is the first approved drug for chronic weight management in adults with general obesity or overweight since 2014, the FDA said. Semaglutide is indicated for chronic weight management in patients with a body mass index (BMI) of 27 kg/m² or greater who have at least 1 weight-related condition, such as the type 2 diabetes (T2D), high blood pressure, or high cholesterol, or alone in patients with a BMI of 30 kg/m² or greater without weigh-related ailments.

For this indication, the 2.4-mg once-weekly injection will be sold under the name Wegovy. The approval was granted to Novo Nordisk. As a 1-mg injection, the drug is sold as Ozempic and was first approved as a treatment for T2D in 2017.

“Today’s approval offers adults with obesity or overweight a beneficial new treatment option to incorporate into a weight management program,” said John Sharretts, MD, deputy director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, in a statement.

Semaglutide works by mimicking a hormone called glucagon-like peptide-1 (GLP-1) that targets areas of the brain that regulate appetite and food intake. The dose must be increased gradually over 16 to 20 weeks to 2.4 mg once weekly to reduce gastrointestinal side effects.

Safety and efficacy were studied in four 68-week trials. Three were randomized, double-blind, placebo-controlled trials (including 16 weeks of dose increases) and one was a double-blind, placebo-controlled, randomized withdrawal trial in which patients receiving semaglutide either continued with the treatment or switched to a placebo. More than 2600 patients received semaglutide for up to 68 weeks in these 4 studies; more than 1500 patients received placebo.