This picture offered by Novo Nordisk in January 2023 exhibits packaging for the corporate’s Wegovy medicine. The favored 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 Meals and Drug Administration mentioned Friday.
Novo Nordisk through AP
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Novo Nordisk through AP
This picture offered by Novo Nordisk in January 2023 exhibits packaging for the corporate’s Wegovy medicine. The favored 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 Meals and Drug Administration mentioned Friday.
Novo Nordisk through AP
The favored weight-loss drug Wegovy, which has helped tens of millions of People 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. Meals and Drug Administration permitted a label change requested by drugmaker Novo Nordisk that expands using semaglutide.
The choice was primarily based on the outcomes of a examine that discovered that Wegovy reduce the danger of significant coronary heart issues — together with coronary heart assault, stroke and heart-related deaths. Greater-weight sufferers with coronary heart illness however not diabetes had been 20% much less prone to expertise these issues in contrast with sufferers who took placebo, or dummy photographs, the examine discovered.
Wegovy is the primary medicine permitted to assist stop the doubtless life-threatening occasions on this inhabitants, the company mentioned.
“Offering a remedy choice that’s confirmed to decrease this cardiovascular threat is a serious advance for public well being,” mentioned Dr. John Sharretts, who directs FDA’s division of diabetes, lipid problems and weight problems.
The transfer will change the way in which many coronary heart sufferers are handled, mentioned Dr. Martha Gulati, a heart specialist at Cedars-Sinai Medical Heart in Los Angeles. It confirms that the brand new class of weight problems drugs are helpful for enhancing well being, not simply shedding weight.
“The hope is that insurers will begin understanding that this isn’t an arrogance drug,” mentioned Gulati, who estimated that almost 70% of her coronary heart sufferers could possibly be eligible for remedy.
Wegovy is a higher-dose model of Ozempic, the diabetes remedy that was beforehand permitted to chop the danger of significant coronary heart issues in folks with that illness. The load-loss drug usually prices about $1,300 a month.
Novo Nordisk has additionally requested European Union regulators to increase 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. Different doable uncomfortable side effects can embody low blood sugar; pancreas, gallbladder, kidney or eye issues; and suicidal habits or pondering.
A couple of third of the greater than 17,600 contributors within the scientific trial reported severe uncomfortable side effects. About 17% within the group that took Wegovy and about 8% of those that obtained placebo left the examine due to these results.
The brand new indication might improve protection of the drug by Medicare, consultants mentioned. The federal medical health insurance program for older People is at the moment barred by regulation from overlaying medication for weight reduction alone. The company spent practically $3 billion in 2021 overlaying Ozempic to deal with diabetes, in response to newest out there figures.
“I am unsure it opens the floodgates, however it will open the door to permit extra folks on Medicare to realize entry to Wegovy,” mentioned Tricia Neuman, a Medicare coverage specialist at KFF, a nonprofit that researches well being coverage.
Wegovy’s new use should bear evaluation by personal insurers
Non-public insurers will consider the brand new indication for Wegovy earlier than making protection selections, mentioned a spokesperson for AHIP, America’s Well being Insurance coverage Plans, an business commerce group.
Drugmakers and weight problems advocates have been pushing for expanded protection, together with laws that might require Medicare to pay for the weight problems medication.
At difficulty has been whether or not the price of the costly drugs will probably be offset by the financial savings of decreased spending on medical care associated to weight problems — and, now, coronary heart illness.
One lingering impediment to broader use is proscribed provide of the drug, which has been in scarcity for greater than a 12 months, in response to the FDA. Novo Nordisk officers say they’re working to extend manufacturing.
Wider entry cannot come quickly sufficient, mentioned Gulati.
“Everyone’s ready to get this medicine,” she mentioned. “Decrease the associated fee, do not be grasping and ensure the drug is accessible to be used.”