This picture offered 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 critical cardiovascular issues in sufferers who’re chubby or who’ve weight problems, the Meals and Drug Administration mentioned Friday.
Novo Nordisk by way of AP
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Novo Nordisk by way of AP
This picture offered 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 critical cardiovascular issues in sufferers who’re chubby or who’ve weight problems, the Meals and Drug Administration mentioned Friday.
Novo Nordisk by way of 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 critical cardiovascular issues in sufferers who’re chubby or who’ve weight problems, federal regulators mentioned Friday.
The U.S. Meals and Drug Administration authorised a label change requested by drugmaker Novo Nordisk that expands using semaglutide.
The choice was based mostly on the outcomes of a examine that discovered that Wegovy reduce the danger of great coronary heart issues — together with coronary heart assault, stroke and heart-related deaths. Increased-weight sufferers with coronary heart illness however not diabetes have been 20% much less more likely to expertise these issues in contrast with sufferers who took placebo, or dummy photographs, the examine discovered.
Wegovy is the primary treatment authorised to assist forestall the possibly life-threatening occasions on this inhabitants, the company mentioned.
“Offering a remedy choice that’s confirmed to decrease this cardiovascular danger is a significant 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 Middle 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,” mentioned Gulati, who estimated that almost 70% of her coronary heart sufferers might be eligible for remedy.
Wegovy is a higher-dose model of Ozempic, the diabetes remedy that was beforehand authorised to chop the danger of great 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 unwanted side effects
The FDA cautioned that Wegovy carries the danger of great unwanted side effects, together with thyroid tumors and sure cancers. Different attainable unwanted side effects can embody low blood sugar; pancreas, gallbladder, kidney or eye issues; and suicidal conduct or pondering.
A few third of the greater than 17,600 individuals within the medical trial reported critical unwanted side effects. About 17% within the group that took Wegovy and about 8% of those that acquired placebo left the examine due to these results.
The brand new indication may enhance protection of the drug by Medicare, consultants mentioned. The federal medical health insurance program for older Individuals is at present barred by legislation from masking medicine for weight reduction alone. The company spent almost $3 billion in 2021 masking Ozempic to deal with diabetes, in accordance with newest obtainable figures.
“I am undecided it opens the floodgates, however it could 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 bear overview by non-public insurers
Personal 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 will require Medicare to pay for the weight problems medicine.
At problem has been whether or not the price of the costly medicines shall 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 accordance with the FDA. Novo Nordisk officers say they’re working to extend manufacturing.
Wider entry cannot come quickly sufficient, mentioned Gulati.
“All people’s ready to get this treatment,” she mentioned. “Decrease the price, do not be grasping and ensure the drug is offered to be used.”
