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There’s a new treatment on the market for patients with cardiovascular disease: Wegovy.
The FDA on Friday approved the GLP-1—an injectable drug developed to treat Type 2 diabetes that’s become a popular weight loss tool—to reduce the risk of heart attack, stroke, and cardiovascular death in certain patients with cardiovascular disease.
John Sharretts, director of the FDA Center for Drug Evaluation and Research’s Division of Diabetes, Lipid Disorders, and Obesity, noted that Wegovy is “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.”
“This patient population has a higher risk of cardiovascular death, heart attack, and stroke,” he said in a statement. “Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health.”
Executives with Novo Nordisk, which sells Wegovy, noted that the expanded label use for the drug follows a clinical trial that found the GLP-1 “statistically significantly reduced the risk of [major adverse cardiovascular events].” Novo Nordisk has applied for a similar label expansion in Europe.
“This approval is an important milestone for people living with obesity and cardiovascular disease, as the [clinical trial] data demonstrated that Wegovy has the potential to prolong lives by addressing some of the leading causes of preventable deaths,” Martin Holst Lange, Novo Nordisk’s EVP of development, said in a statement.
The FDA approved Wegovy to treat Type 2 diabetes in 2017 and for chronic weight management in 2021.