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FDA approves Wegovy to reduce risk of heart disease, stroke in overweight patients


This image provided by Novo Nordisk in January 2023 shows packaging for the company’s Wegovy drug. The popular weight-loss drug can now be used to reduce the risk of stroke, heart attack and other serious cardiovascular problems in people who are overweight or obese, the Food and Drug Administration said Friday.

Novo Nordisk (AP)


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Novo Nordisk (AP)


This image provided by Novo Nordisk in January 2023 shows packaging for the company’s Wegovy drug. The popular weight-loss drug can now be used to reduce the risk of stroke, heart attack and other serious cardiovascular problems in people who are overweight or obese, the Food and Drug Administration said Friday.

Novo Nordisk (AP)

The popular weight-loss drug Wegovy, which has helped millions of Americans lose weight, is now available to reduce the risk of stroke, heart disease and other serious cardiovascular problems in people who are overweight or obese. Federal regulators said Friday.

The U.S. Food and Drug Administration approved a label change requested by drugmaker Novo Nordisk that expanded the use of semaglutide.

The decision was based on the results of a study that found Wegovy could reduce the risk of serious heart problems, including heart attack, stroke and heart-related death. Higher-weight patients with heart disease but not diabetes were 20 percent less likely to develop heart disease, the study found, compared with patients who received a placebo or dummy injection.

Wegovy is the first drug approved to help prevent potentially life-threatening events in this population, the agency said.

“Providing a treatment option proven to reduce cardiovascular risk is a significant advance for public health,” said Dr. John Sharretts, director of the FDA’s Division of Diabetes, Lipid Disorders and Obesity.

Dr. Martha Gulati, a cardiologist at Cedars-Sinai Medical Center in Los Angeles, said the move will change the way many heart disease patients are treated. It confirms that new obesity drugs can not only reduce weight but also improve health.

“Hopefully insurance companies will start to understand that this is not a vanity drug,” said Gulati, who estimates that nearly 70 percent of her heart disease patients qualify for the treatment.

Wegovy is the high dose version ozone, a diabetes treatment previously approved to reduce the risk of serious heart disease in people with diabetes. This weight-loss drug typically costs about $1,300 per month.

Novo Nordisk has also asked EU regulators to expand the drug’s use to treat heart disease, but EU regulators have yet to comment on the request.

FDA warns about side effects

The FDA warns that Wegovy carries a risk of serious side effects, including thyroid tumors and certain cancers. Other possible side effects include low blood sugar, pancreas, gallbladder, kidney, or eye problems, and suicidal behavior or thoughts.

About one-third of the more than 17,600 participants in clinical trials reported serious side effects. About 17% of subjects taking Wegovy and about 8% of subjects receiving placebo dropped out of the study because of these side effects.

Experts say the new indication could increase Medicare coverage of the drug. Currently, the federal health insurance program for older Americans is prohibited by law from covering only weight-loss drugs. The agency spent nearly $3 billion in 2021 to insure Ozempic to treat diabetes. Based on the latest available data.

“I’m not sure it will open the floodgates, but it will open the door to more people on Medicare being able to use Wegovy,” said Tricia Neuman, a health insurance policy expert at KFF, a nonprofit that studies health insurance.

New uses of Wegovy must be reviewed by private insurance companies

A spokesman for America’s Health Insurance Plans (AHIP), an industry trade group, said private insurers will evaluate Wegovy’s new indication before making coverage decisions.

Drugmakers and obesity advocates have been pushing for expanded coverage, including legislation that would require Medicare to cover the cost of obesity drugs.

The question is whether the cost of expensive drugs will be offset by savings from reduced medical spending related to obesity and now heart disease.

Limited supply of the drug, which has been in short supply for more than a year, is a lingering obstacle to widespread use, according to the FDA. Novo Nordisk officials said they are working to increase production.

Gulati said broader access cannot come soon enough.

“Everyone is waiting to get this drug,” she said. “Keep the cost down, don’t be greedy and make sure the drug is available.”



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