“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, M.D., director in FDA’s Center for Drug Evaluation and Research, said in a statement Friday.
“We are very pleased that Wegovy is now approved in the U.S. as the first therapy to help people manage their weight and reduce cardiovascular risks,” Martin Holst Lange, a Novo Nordisk executive vice president, said in a statement.
The FDA’s expansion of Wegovy’s regulatory label comes after a closely watched clinical trial last year found that the drug dramatically reduced the risk of heart problems for overweight people. Demand for Wegovy has been so intense that Novo Nordisk has struggled to churn out enough, leading the FDA to declare the drug in shortage. The company is taking extraordinary measures to ramp up production, including acquiring a contract manufacturer.
This is a developing story and will be updated.
Rachel Carter is a health and wellness expert dedicated to helping readers lead healthier lives. With a background in nutrition, she offers evidence-based advice on fitness, nutrition, and mental well-being.