The FDA has approved Wegovy, Novo Nordisk's version of semaglutide approved for weight loss, to be used to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and either obesity or overweight.
"Wegovy is now the first weight loss medication to also be approved to help prevent life-threatening cardiovascular events in adults with cardiovascular disease and either obesity or overweight," John Sharretts, MD, director of the division of diabetes, lipid disorders and obesity in the FDA's Center for Drug Evaluation and Research, said in a March 8 press release from the organization. "This patient population has a higher risk of cardiovascular death, heart attack and stroke. Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health."
Obesity impacts approximately 70% of American adults and can lead to heart attacks and stroke.
The medication was approved for the new indication following a study of 17,600 patients who received either Wegovy or a placebo. Participants in both groups also received standard-of-care medical treatment and healthy lifestyle counseling.
Wegovy significantly reduced the risk of major adverse cardiovascular events, which occurred in 6.5% of participants who received Wegovy compared to 8% of participants who received placebo.