This picture supplied by Novo Nordisk in January 2023 exhibits packaging for the corporate’s Wegovy remedy. The fashionable weight-loss drug can now be used to cut back the danger of stroke, coronary heart assaults and different severe cardiovascular issues in sufferers who’re obese or who’ve weight problems, the Food and Drug Administration mentioned Friday.
Novo Nordisk through AP
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Novo Nordisk through AP
This picture supplied by Novo Nordisk in January 2023 exhibits packaging for the corporate’s Wegovy remedy. The fashionable weight-loss drug can now be used to cut back the danger of stroke, coronary heart assaults and different severe cardiovascular issues in sufferers who’re obese or who’ve weight problems, the Food and Drug Administration mentioned Friday.
Novo Nordisk through AP
The fashionable weight-loss drug Wegovy, which has helped thousands and thousands of Americans shed kilos, can now be used to cut back the danger of stroke, coronary heart assaults and different severe cardiovascular issues in sufferers who’re obese or who’ve weight problems, federal regulators mentioned Friday.
The U.S. Food and Drug Administration authorised a label change requested by drugmaker Novo Nordisk that expands using semaglutide.
The determination was based mostly on the outcomes of a research that discovered that Wegovy reduce the danger of significant coronary heart issues — together with coronary heart assault, stroke and heart-related deaths. Higher-weight sufferers with coronary heart illness however not diabetes had been 20% much less more likely to expertise these issues in contrast with sufferers who took placebo, or dummy pictures, the research discovered.
Wegovy is the primary remedy authorised to assist stop the doubtless life-threatening occasions on this inhabitants, the company mentioned.
“Providing a therapy possibility that’s confirmed to decrease this cardiovascular danger is a serious advance for public well being,” mentioned Dr. John Sharretts, who directs FDA’s division of diabetes, lipid issues and weight problems.
The transfer will change the best way many coronary heart sufferers are handled, mentioned Dr. Martha Gulati, a heart specialist at Cedars-Sinai Medical Center in Los Angeles. It confirms that the brand new class of weight problems drugs are helpful for bettering well being, not simply shedding pounds.
“The hope is that insurers will begin understanding that this isn’t a conceit drug,” mentioned Gulati, who estimated that almost 70% of her coronary heart sufferers could possibly be eligible for therapy.
Wegovy is a higher-dose model of Ozempic, the diabetes therapy that was beforehand authorised to chop the danger of significant coronary heart issues in folks with that illness. The weight-loss drug sometimes prices about $1,300 a month.
Novo Nordisk has additionally requested European Union regulators to develop using the drug for coronary heart issues. EU regulators haven’t weighed in on the request.
The FDA warns of uncomfortable side effects
The FDA cautioned that Wegovy carries the danger of significant uncomfortable side effects, together with thyroid tumors and sure cancers. Other doable uncomfortable side effects can embrace low blood sugar; pancreas, gallbladder, kidney or eye issues; and suicidal habits or pondering.
About a 3rd of the greater than 17,600 contributors within the medical trial reported severe uncomfortable side effects. About 17% within the group that took Wegovy and about 8% of those that obtained placebo left the research due to these results.
The new indication might improve protection of the drug by Medicare, specialists mentioned. The federal medical health insurance program for older Americans is at the moment barred by legislation from overlaying medicine for weight reduction alone. The company spent almost $3 billion in 2021 overlaying Ozempic to deal with diabetes, in keeping with newest obtainable figures.
“I’m unsure it opens the floodgates, however it will open the door to permit extra folks on Medicare to achieve entry to Wegovy,” mentioned Tricia Neuman, a Medicare coverage specialist at KFF, a nonprofit that researches well being coverage.
Wegovy’s new use should endure overview by personal insurers
Private insurers will consider the brand new indication for Wegovy earlier than making protection choices, mentioned a spokesperson for AHIP, America’s Health Insurance Plans, an trade commerce group.
Drugmakers and weight problems advocates have been pushing for expanded protection, together with laws that may require Medicare to pay for the weight problems medicine.
At problem has been whether or not the price of the costly drugs might be offset by the financial savings of diminished spending on medical care associated to weight problems — and, now, coronary heart illness.
One lingering impediment to broader use is restricted provide of the drug, which has been in scarcity for greater than a 12 months, in keeping with the FDA. Novo Nordisk officers say they’re working to extend manufacturing.
Wider entry cannot come quickly sufficient, mentioned Gulati.
“Everybody’s ready to get this remedy,” she mentioned. “Lower the price, do not be grasping and ensure the drug is obtainable to be used.”