The U.S. Food and Drug Administration on Friday approved Wegovy, a higher-dose version of Novo Nordisk's (NVO) diabetes drug semaglutide, for chronic weight management in adults with obesity.
This 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 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.
In studies, individuals who received Wegovy lost an average of 12.4% of their initial body weight compared to individuals who received placebo.
"Today's approval offers adults with obesity or overweight a beneficial new treatment option to incorporate into a weight management program," said John Sharretts, M.D., 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."
In the U.S., approximately 70% of American adults have obesity or overweight. Losing 5% to 10% of body weight through diet and exercise has been associated with a reduced risk of cardiovascular disease in adult patients with obesity or overweight.
The FDA granted the approval to Novo Nordisk. Semaglutide 1 mg injection was first approved as a treatment for type 2 diabetes in 2017.
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