Novo Nordisk’s Wegovy wins FDA approval for heart health benefits

The Food and Drug Administration approved Novo Nordisk‘s blockbuster weight loss drug Wegovy for use in slashing the risk of serious cardiovascular complications in people with obesity and heart disease, the company said Friday. 

Millions of patients already use the injectable treatment. But the agency’s 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.

Wegovy reduced the risk of non-fatal heart attack by 28% in the five-year trial. It produced a smaller 7% reduction in the occurrence of non-fatal stroke, though few strokes were seen in the trial overall.

Wegovy also started to show a reduction in overall cardiovascular events within months after participants started the drug. The difference between the drug and placebo widened as the study continued.

“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.

The new data could also help the Danish drugmaker maintain its lead over Eli Lilly, whose competing weight-loss drug Zepbound was approved in the U.S. in November. Zepbound has been shown to help people lose more weight, but it has yet to demonstrate an effect on cardiovascular outcomes. 

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