FDA Approves Wegovy for Reducing Cardiovascular Risks

The US Food and Drug Administration (FDA) approved the Wegovy (semaglutide) injection for reducing the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease who are obese or overweight.

Around 70% of American adults are obese or overweight, and they have an increased risk of premature death and a variety of health problems, including heart attack and stroke.

The efficacy and safety of Wegovy for this new indication were assessed in a multinational, multicenter, placebo-controlled, double-blind trial comprising 17,600 participants randomly assigned to receive either Wegovy or placebo. Participants in both groups also received standard-of-care medical treatment, such as blood pressure and cholesterol control and healthy lifestyle counseling.

According to the study’s findings, 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 with 8.0% of those who received placebo.

“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, MD, director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, via a press release. “This patient population has a higher risk of cardiovascular death, heart attack, and stroke. Providing a treatment option that is proven to lower cardiovascular risk is a major advance for public health.”