FDA announced the decision to approve the GLP-1 receptor agonist, semaglutide (Wegovy), to reduce the risk of CV death, heart attack, and stroke in adults with CVD and 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,” said John Sharretts, MD, from FDA’s Center for Drug Evaluation and Research, in a news release. “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.”
Semaglutide was originally approved for T2D and then in 2021 for chronic weight management in adults with obesity or overweight.
The new approval is based on data from a 5-year clinical trial, which included more than 17,600 patients with obesity and overweight, both with and without T2D, as well as pre-existing CVD. When compared to placebo, researchers found that patients taking semaglutide when added to standard of care had a 20% reduction in heart attack, stroke, and CV death. The exact mechanism of CV risk reduction has not been established.
With the new approval, FDA noted that semaglutide should be used in conjunction with a reduced calorie diet and increased physical activity.
The clinical trial, called SELECT, was funded by semaglutide maker Novo Nordisk.