Novo Nordisk gets FDA OK for new indication for Wegovy

The Food and Drug Administration approved a new indication for use for Novo Nordisk A/S’s Wegovy (semaglutide) injection to reduce the risk of cardiovascular death, heart attack and stroke in overweight or obese adults with cardiovascular disease. Cardiovascular disease is a group of diseases of the heart and blood vessels.

Wegovy should be used in addition to a reduced calorie diet and increased physical activity, the FDA said.

"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, director of the division of diabetes, lipid disorders and obesity in the FDA's Center for Drug Evaluation and Research. "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." 

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Wegovy is now also indicated to reduce the risk of serious heart problems in adults with obesity or overweight.

Obesity or overweight affect approximately 70% of American adults. Obesity and overweight are serious health issues that increase the risk for premature death and a variety of health problems, including heart attack and stroke, the FDA said.

Wegovy contains semaglutide, a glucagon-like peptide-1 receptor agonist. Therefore, Wegovy should not be used in combination with other semaglutide-containing products or other GLP-1 receptor agonists.

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Wegovy also is approved to reduce excess weight and maintain weight reduction long term in certain adults with obesity or overweight and certain children with obesity, for use in addition to a reduced calorie diet and increased physical activity.

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