FDA approves weight-loss drug Wegovy to reduce heart-disease risks

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The U.S. Food and Drug administration approved the weight-loss drug Wegovy as a treatment to reduce cardiovascular risk in adults who are overweight, the first approval of its kind that could dramatically expand the already huge market for the drug.

Wegovy, which has the same active ingredient as diabetes drug Ozempic, already had FDA approval to treat patients who are obese or overweight. It has become a cultural sensation and a blockbuster, bringing in billions of dollars in revenue for its manufacturer, Novo Nordisk.

“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.

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