The Food and Drug Administration approved it on Friday. novo nordiskThe blockbuster weight loss drug Wegovy is used to reduce the risk of serious cardiovascular complications in adults with obesity and heart disease.

Millions of patients are already using the popular injectable treatment. But the agency’s decision could result in an expansion of expensive insurance coverage. Drug therapy and similar treatments for obesity pose major barriers to access for patients.

The approval also shows that weight loss drugs have significant health benefits beyond shedding unwanted weight and regulating blood sugar levels. A landmark late-stage study of the drug found that weekly Wegovy injections reduced the overall risk of heart attack, stroke, and death from cardiovascular disease by 20%.

Dr. John Sharetz, director of the Division of Diabetes, Dyslipidemia, and Obesity in the FDA’s Center for Drug Evaluation and Research, said in a release that Wigovy is the first weight-loss drug to receive expanded approval for that purpose. .

He noted that adults with obesity and heart disease are at higher risk for these cardiovascular complications, so providing treatment options proven to reduce that risk is “a major advance for public health.” .

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

Wegovy and its low-dose diabetes product, Ozempic, have seen a surge in demand and shortages over the past year due to their effectiveness in helping patients lose significant weight over time.

These are part of a class of drugs that mimic a hormone called GLP-1, which is produced in the intestines to suppress a person’s appetite. Both Wegovy and Ozempic cost about $1,000 per month before insurance.

Novo Nordisk said in a statement Friday that the approval is “a vital step forward in addressing some of the most pressing issues of our time.” The company added that it is working to increase its manufacturing capacity to “responsibly supply this important medicine.”

Novo Nordisk plans to obtain similar approval for Wegovy in the EU this year.

The FDA’s approval was based on a groundbreaking Phase 3 trial called SELECT. The study tested Wegovy on about 17,500 people who were obese and had heart disease but did not have diabetes.

Wegovy reduced the risk of nonfatal heart attacks by 28% in a five-year trial. Although there were very few strokes in the trial overall, there was a 7% reduction in non-fatal strokes.

Wegovy also started showing reductions in overall cardiovascular events within a few months of participants starting taking the drug. As the study continued, the difference between the drug and the placebo widened.

Nearly 17% of people who received Wegovy in the trial stopped taking the drug, primarily due to gastrointestinal issues such as vomiting and diarrhea. This is twice the rate of those who stopped taking the placebo.

Another limitation of this study was the lack of diversity. Almost three-quarters of the participants were male, and even more were white. Only about 4% of participants were Black.

New data could also help Danish drugmaker maintain lead over others Eli LillyThe company’s competing weight loss drug, Zepbound, was approved in the U.S. in November. Zepbound has been shown to help people lose more weight, but its effects on cardiovascular disease have not yet been proven.