This picture supplied by Novo Nordisk in January 2023 reveals packaging for the corporate’s Wegovy treatment. 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 stated Friday.
Novo Nordisk through AP
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Novo Nordisk through AP
This picture supplied by Novo Nordisk in January 2023 reveals packaging for the corporate’s Wegovy treatment. 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 stated Friday.
Novo Nordisk through AP
The favored weight-loss drug Wegovy, which has helped hundreds of thousands of Individuals 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 stated Friday.
The U.S. Meals and Drug Administration accepted a label change requested by drugmaker Novo Nordisk that expands the usage of semaglutide.
The choice was primarily based 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. Increased-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 pictures, the research discovered.
Wegovy is the primary treatment accepted to assist forestall the doubtless life-threatening occasions on this inhabitants, the company stated.
“Offering a therapy choice that’s confirmed to decrease this cardiovascular danger is a significant advance for public well being,” stated Dr. John Sharretts, who directs FDA’s division of diabetes, lipid issues and weight problems.
The transfer will change the way in which many coronary heart sufferers are handled, stated Dr. Martha Gulati, a heart specialist at Cedars-Sinai Medical Heart in Los Angeles. It confirms that the brand new class of weight problems medicines are helpful for bettering well being, not simply dropping pounds.
“The hope is that insurers will begin understanding that this isn’t a conceit drug,” stated Gulati, who estimated that just about 70% of her coronary heart sufferers might be eligible for therapy.
Wegovy is a higher-dose model of Ozempic, the diabetes therapy that was beforehand accepted to chop the danger of significant coronary heart issues in folks with that illness. The load-loss drug sometimes prices about $1,300 a month.
Novo Nordisk has additionally requested European Union regulators to increase the usage of 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 members 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 research due to these results.
The brand new indication might improve protection of the drug by Medicare, consultants stated. The federal medical health insurance program for older Individuals is at present barred by regulation from protecting medicine for weight reduction alone. The company spent almost $3 billion in 2021 protecting Ozempic to deal with diabetes, in keeping with newest accessible figures.
“I am undecided it opens the floodgates, however it could open the door to permit extra folks on Medicare to realize entry to Wegovy,” stated Tricia Neuman, a Medicare coverage specialist at KFF, a nonprofit that researches well being coverage.
Wegovy’s new use should bear overview by personal insurers
Personal insurers will consider the brand new indication for Wegovy earlier than making protection choices, stated a spokesperson for AHIP, America’s Well being Insurance coverage Plans, an trade commerce group.
Drugmakers and weight problems advocates have been pushing for expanded protection, together with laws that will require Medicare to pay for the weight problems medicine.
At subject has been whether or not the price of the costly medicines will likely 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 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, stated Gulati.
“Everyone’s ready to get this treatment,” she stated. “Decrease the fee, do not be grasping and ensure the drug is accessible to be used.”
