This picture offered by Novo Nordisk in January 2023 exhibits packaging for the corporate’s Wegovy treatment. The favored weight-loss drug can now be used to scale 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
cover caption
toggle caption
Novo Nordisk through AP
This picture offered by Novo Nordisk in January 2023 exhibits packaging for the corporate’s Wegovy treatment. The favored weight-loss drug can now be used to scale 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 thousands and thousands of Individuals shed kilos, can now be used to scale 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 accredited 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 lower the danger of great coronary heart issues — together with coronary heart assault, stroke and heart-related deaths. Greater-weight sufferers with coronary heart illness however not diabetes have 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 treatment accredited to assist forestall the doubtless 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 Heart in Los Angeles. It confirms that the brand new class of weight problems medicines 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 may very well be eligible for remedy.
Wegovy is a higher-dose model of Ozempic, the diabetes remedy that was beforehand accredited to chop the danger of great coronary heart issues in folks with that illness. The burden-loss drug sometimes prices about $1,300 a month.
Novo Nordisk has additionally requested European Union regulators to broaden using the drug for coronary heart issues. EU regulators haven’t weighed in on the request.
The FDA warns of unwanted effects
The FDA cautioned that Wegovy carries the danger of great unwanted effects, together with thyroid tumors and sure cancers. Different potential unwanted effects can embrace low blood sugar; pancreas, gallbladder, kidney or eye issues; and suicidal habits or pondering.
A few third of the greater than 17,600 contributors within the medical trial reported severe unwanted 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 might enhance protection of the drug by Medicare, specialists mentioned. The federal medical health insurance program for older Individuals is presently barred by legislation from masking medicine for weight reduction alone. The company spent practically $3 billion in 2021 masking Ozempic to deal with diabetes, based on newest out there figures.
“I am undecided it opens the floodgates, however it might 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 endure assessment by personal insurers
Non-public insurers will consider the brand new indication for Wegovy earlier than making protection choices, 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 may require Medicare to pay for the weight problems medicine.
At situation has been whether or not the price of the costly medicines will likely 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, based on 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 treatment,” she mentioned. “Decrease the fee, do not be grasping and ensure the drug is obtainable to be used.”
