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FDA Approves First Treatment to Reduce Risk of Serious Heart Problems Specifically in Adults with Obesity or Overweight

On March 8, the U.S. Food and Drug Administration approved a new indication for use for Wegovy (semaglutide) injection to reduce the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease and either obesity or overweight. Wegovy should be used in addition to a reduced-calorie diet and increased physical activity. Cardiovascular disease is a group of diseases of the heart and blood vessels. 

Wegovy is also approved to reduce excess weight and maintain weight reduction long term in certain adults with obesity or overweight and certain children with obesity, for use in addition to a reduced calorie diet and increased physical activity.

“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,” said John Sharretts, M.D., director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research. “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 or overweight affects approximately 70% of American adults. Obesity and overweight are serious health issues that increase the risk for premature death and a variety of health problems, including heart attack and stroke.

Wegovy contains semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist. Therefore, Wegovy should not be used in combination with other semaglutide-containing products or other GLP-1 receptor agonists.

Wegovy’s efficacy and safety for this new indication were studied in a multi-national, multi-center, placebo-controlled double-blind trial that randomly assigned over 17,600 participants to receive either Wegovy or a placebo. Participants in both groups also received standard-of-care medical treatment (e.g., management of blood pressure and cholesterol) and healthy lifestyle counseling (including diet and physical activity). Wegovy significantly reduced the risk of major adverse cardiovascular events (cardiovascular death, heart attack, and stroke), which occurred in 6.5% of participants who received Wegovy compared to 8% of participants who received a placebo.