The favored weight-loss drug Wegovy, which has helped tens of millions of Americans shed kilos, can now be used to reduce the risk of stroke, heart attacks and other serious cardiovascular problems in patients who’re obese or who’ve obesity, federal regulators said Friday.
The Food and Drug Administration approved a label change requested by drugmaker Novo Nordisk that expands using semaglutide.
The choice was based on the results of a study that found that Wegovy cut the risk of great 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 primary medication approved to help prevent the doubtless life-threatening events on this population, the agency said.
“Providing a treatment option that’s proven to lower this cardiovascular risk is a serious 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 in which many heart patients are treated, said Dr. Martha Gulati, a cardiologist at Cedars-Sinai Medical Center in Los Angeles. It confirms that the brand new class of obesity medications are useful for improving health, not only shedding weight.
“The hope is that insurers will start understanding that this is just not a conceit drug,” said Gulati, who estimated that almost 70% of her heart patients could possibly be eligible for treatment.
Wegovy is a higher-dose version of Ozempic, the diabetes treatment that was previously approved to cut the risk of great heart problems in individuals with that disease. The burden-loss drug typically costs about $1,300 a month.
Novo Nordisk has also asked European Union regulators to expand using the drug for heart problems. EU regulators haven’t weighed in on the request.
The FDA cautioned that Wegovy carries the risk of great unwanted side effects, including thyroid tumors and certain cancers. Other possible unwanted side effects can include low blood sugar; pancreas, gallbladder, kidney or eye problems; and suicidal behavior or pondering.
A few third of the greater than 17,600 participants within the clinical trial reported serious unwanted side effects. About 17% within the group that took Wegovy and about 8% of those that received placebo left the study due to those effects.
The brand new indication could increase coverage of the drug by Medicare, experts said. The federal medical insurance program for older Americans is currently barred by law from covering drugs for weight reduction alone. The agency spent nearly $3 billion in 2021 covering Ozempic to treat diabetes, according to latest available figures.
“I’m unsure it opens the floodgates, nevertheless 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.
Private insurers will evaluate the brand 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 laws that will require Medicare to pay for the obesity drugs.
At issue has been whether the fee of the expensive medications shall 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 proscribed supply of the drug, which has been in shortage for greater than a yr, 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 fee, don’t be greedy and ensure the drug is out there to be used.”