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 overweight or obese patients, federal regulators said Friday.
The U.S. Food and Drug Administration has 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 showed Wegovy reduced 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 these problems compared with patients who took a placebo or dummy injections, the study found.
Wegovy is the first drug approved to help prevent the potentially life-threatening events in this population, the agency said.
“Providing a treatment option proven to reduce this cardiovascular risk is a major advance for public health,” said Dr. John Sharretts, who heads the 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 anti-obesity drugs is useful for improving health, not just weight loss.
“The hope is that insurers will come to understand that this is not a vanity drug,” said Gulati, who estimated that nearly 70% of her heart patients could qualify for treatment.
Wegovy is a higher-dose version of Ozempic, the diabetes treatment previously approved to reduce the risk of serious heart problems in people with that disease. The weight-loss drug typically costs about $1,300 per month.
Novo Nordisk has also asked European Union regulators to expand the drug’s use for heart problems. EU regulators did not respond to the request.
The FDA warned that Wegovy carries the 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 thinking.
About a third of the more than 17,600 participants in the clinical trial reported serious side effects. About 17% of the group taking Wegovy and about 8% of those given a placebo left the study because of these effects.
The new indication could increase the drug’s coverage by Medicare, experts said. The federal health insurance program for older Americans is currently prohibited by law from covering only weight loss medications. The agency spent nearly $3 billion on Ozempic to treat diabetes in 2021, according to the latest available figures.
“I’m not sure if this opens the floodgates, but it would open the door to getting more people with Medicare access to Wegovy,” said Tricia Neuman, a Medicare policy specialist at KFF, a nonprofit that conducts health policy research.
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.
Drug manufacturers and obesity advocates have pushed for expanded coverage, including legislation that would require Medicare to pay for the obesity drugs.
The question is whether the costs of the expensive drugs will be offset by the savings from lower medical care expenditures related to obesity – and now cardiovascular disease.
A lingering obstacle to broader use is the drug’s limited supply, which the FDA says has been in short supply for more than a year. Novo Nordisk officials say they are working to increase production.
Wider access can’t come soon enough, Gulati said.
“Everyone is waiting for this medicine,” she said. “Reduce costs, don’t be greedy and make sure the medicine is available for use.”
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