In this photo illustration, injectable pens of the weight loss drug Wegovy from Novo Nordisk are shown in Oslo, Norway, on November 21, 2023.
Victoria Klesty | Reuters
The Food and Drug Administration on Friday approved NordiskWegovy, the blockbuster weight loss drug, for use in reducing 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 expand insurance coverage for expensive medications and similar treatments for obesity, which has been a major barrier to access for patients.
The approval also demonstrates that weight-loss drugs have important health benefits beyond shedding unwanted pounds and regulating blood sugar. Wegovy is now the first weight-loss drug whose use has been expanded to prevent life-threatening cardiovascular events, meaning death, heart attack and stroke, the FDA said in a statement.
Adults with obesity and heart disease face a higher risk of these complications, so “providing a treatment option that has been shown to reduce this cardiovascular risk is an important public health advance,” said Dr. John Sharretts, director of the Diabetes Division, Lipids. Disorders and obesity at the FDA Center for Drug Evaluation and Research.
The FDA said Wegovy patients should use Wegovy in addition to a low-calorie diet and increased physical activity.
Wegovy and its diabetes counterpart, Ozempic, sparked a gold rush in the weight loss industry over the past year for their ability to help patients lose significant weight over time. They are part of a class of medications that mimic a hormone produced in the intestine 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 about 17,500 people with obesity and heart disease but who did not have diabetes.
Weekly injections of Wegovy reduced the overall risk of heart attack, stroke and death from cardiovascular causes by 20%, according to detailed trial results 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 strokes, although few strokes were seen in the trial overall.
Wegovy also began showing a reduction in overall cardiovascular events a few months after participants started taking the drug. The difference between the drug and placebo widened as the study progressed.
“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 statement.
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 United States in November. Zepbound has been shown to help people lose more weight, but has yet to demonstrate an effect on cardiovascular outcomes.
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