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Novo Nordisk’s Wegovy wins FDA approval for cutting heart disease risks, in move that could expand insurance coverage

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 on Friday approved Novo Nordisk‘s blockbuster weight loss drug Wegovy for use in slashing the risk of serious cardiovascular complications in adults with obesity and heart disease.

Millions of patients already use the injectable treatment. But the agency’s decision could widen insurance coverage for the costly 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 is now the first weight loss medication to gain expanded use for preventing life-threatening cardiovascular events, namely death, heart attack and stroke, the FDA said in a release.

Adults with obesity and heart disease face more risk of those complications, so “providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health,” said Dr. John Sharretts, director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research.

The FDA said Wegovy patients should use Wegovy in addition to a reduced calorie diet and increased physical activity.

Wegovy and its diabetes counterpart Ozempic sparked a weight loss industry gold rush over the past year for their ability to help patients lose significant weight over time. 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 phase three 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. 

This is breaking news. Please check back for updates.

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