FDA approves Novo Nordisk's Wegovy

The Food and Drug Administration has approved Novo Nordisk’s Wegovy (semaglutide) injection (2.4 mg once weekly) for chronic weight management in adults with obesity or overweight, with at least one weight-related condition, such as high blood pressure, Type 2 diabetes or high cholesterol, for use in addition to a reduced-calorie diet and increased physical activity.

The under-the-skin injection is the first approved drug for chronic weight management in adults with general obesity or overweight since 2014. The drug is indicated for chronic weight management in patients with a body mass index, or BMI, of 27 kg/m2 or greater who have at least one weight-related ailment, or in patients with a BMI of 30 kg/m2 or greater.

“Today’s approval offers adults with obesity or overweight a beneficial new treatment option to incorporate into a weight management program,” said John Sharretts, deputy director of the division of diabetes, lipid disorders and obesity in the FDA’s Center for Drug Evaluation and Research. “FDA remains committed to facilitating the development and approval of additional safe and effective therapies for adults with obesity or overweight.”

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

Semaglutide 1 mg injection (Ozempic) was first approved as a treatment for Type 2 diabetes in 2017.