The popular weight-loss drug Wegovy, which has helped millions of Americans shed pounds, can now be used to reduce the risk of stroke, heart attacks and other serious cardiovascular problems in patients who are overweight or who have obesity, federal regulators said Friday.
The U.S. Food and Drug Administration approved a label change requested by drugmaker Novo Nordisk that expands the use of semaglutide.
The decision was based on the results of a study that found that Wegovy cut the risk of serious heart problems — including heart attack, stroke and heart-related deaths. Higher-weight patients with heart disease but not diabetes were 20% less likely to experience those problems compared with patients who took placebo, or dummy shots, the study found.
Wegovy is the first medication approved to help prevent the potentially life-threatening events in this population, the agency said.
"Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health," said Dr. John Sharretts, who directs FDA's division of diabetes, lipid disorders and obesity.
The move will change the way many heart patients are treated, said Dr. Martha Gulati, a cardiologist at Cedars-Sinai Medical Center in Los Angeles. It confirms that the new class of obesity medications are useful for improving health, not just losing weight.
"The hope is that insurers will start understanding that this is not a vanity drug," said Gulati, who estimated that nearly 70% of her heart patients could be eligible for treatment.
Wegovy is a higher-dose version of Ozempic, the diabetes treatment that was previously approved to cut the risk of serious heart problems in people with that disease. The weight-loss drug typically costs about $1,300 a month.
Novo Nordisk has also asked European Union regulators to expand the use of the drug for heart problems. EU regulators have not weighed in on the request.
The FDA warns of side effects
The FDA cautioned that Wegovy carries the risk of serious side effects, including thyroid tumors and certain cancers. Other possible side effects can include low blood sugar; pancreas, gallbladder, kidney or eye problems; and suicidal behavior or thinking.
About a third of the more than 17,600 participants in the clinical trial reported serious side effects. About 17% in the group that took Wegovy and about 8% of those who received placebo left the study because of those effects.
The new indication could increase coverage of the drug by Medicare, experts said. The federal health insurance program for older Americans is currently barred by law from covering drugs for weight loss alone. The agency spent nearly $3 billion in 2021 covering Ozempic to treat diabetes, according to latest available figures.
"I'm not sure it opens the floodgates, but it would open the door to allow more people on Medicare to gain access to Wegovy," said Tricia Neuman, a Medicare policy specialist at KFF, a nonprofit that researches health policy.
Wegovy's new use must undergo review by private insurers
Private insurers will evaluate the new indication for Wegovy before making coverage decisions, said a spokesperson for AHIP, America's Health Insurance Plans, an industry trade group.
Drugmakers and obesity advocates have been pushing for expanded coverage, including legislation that would require Medicare to pay for the obesity drugs.
At issue has been whether the cost of the expensive medications will be offset by the savings of reduced spending on medical care related to obesity — and, now, heart disease.
One lingering obstacle to broader use is limited supply of the drug, which has been in shortage for more than a year, according to the FDA. Novo Nordisk officials say they're working to increase production.
Wider access can't come soon enough, said Gulati.
"Everybody's waiting to get this medication," she said. "Lower the cost, don't be greedy and make sure the drug is available for use."
