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Novo Nordisk’s Wegovy wins FDA approval for heart benefits, which could expand insurance coverage

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Injection pens of Novo Nordisk’s weight-loss drug Wegovy are shown in this photo illustration in Oslo, Norway, Nov. 21, 2023.
Victoria Klesty | Reuters

The Food and Drug Administration approved Novo Nordiskslashing the risk of serious cardiovascular complications in people with obesity and heart disease, the company said Friday. 

That decision could widen insurance coverage for the drug and similar treatments for obesity, which has been a major barrier to access for patients. The approval also demonstrates that weight loss drugs have significant health benefits beyond shedding unwanted pounds and regulating blood sugar.

Wegovy and its diabetes counterpart Ozempic sparked a weight loss industry gold rush over the past year for their ability to help patients shed pounds.

They are part of a class of drugs that mimic a hormone produced in the gut called GLP-1 to suppress a person’s appetite. 

The approval was based on a landmark late-stage trial called SELECT. The study tested Wegovy in roughly 17,500 people with obesity and heart disease but who did not have diabetes. 

Weekly injections of Wegovy slashed the overall risk of heart attack, stroke and death from cardiovascular causes by 20%, according to detailed results from the trial Novo Nordisk presented in November.

“This approval is an important milestone for people living with obesity and cardiovascular disease,” Martin Holst Lange, head of development at Novo Nordisk, said in a release.

This is breaking news. Please check back for updates.

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