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Obesity drug Wegovy is approved to cut heart attack and stroke risk in overweight patients

The common weight-loss drug Wegovy, which has helped hundreds of thousands of American citizens let fall kilos, can now be old to release the chance of stroke, coronary heart assaults and alternative critical cardiovascular issues in sufferers who’re obese or who’ve weight problems, federal regulators stated Friday.

The U.S. Meals and Drug Management authorized a label trade asked through drugmaker Novo Nordisk that expands the utility of semaglutide.

The verdict used to be in line with the result of a find out about that discovered that Wegovy trim the chance of great coronary heart issues — together with coronary heart assault, stroke and heart-related deaths. Upper-weight sufferers with coronary heart problem however now not diabetes have been 20% much less more likely to revel in the ones issues when put next with sufferers who took placebo, or dummy pictures, the find out about discovered.

Wegovy is the primary healing authorized to aid stop the doubtless life-threatening occasions on this nation, the company stated.

“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,” stated Gulati, who estimated that just about 70% of her coronary heart sufferers may well be eligible for remedy.

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 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.

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.”


The Related Press Condition and Science Section receives backup from the Howard Hughes Clinical Institute’s Science and Instructional Media Team. The AP is just answerable for all content material.

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