Wegovy goes beyond weight loss

Wegovy, the successful weight loss drug, has now been approved for a new use: reducing the risk of heart attacks, strokes and cardiovascular death in adults with heart disease and overweight or obesity.

The new indication, which the Food and Drug Administration announced Friday, will pave the way for even more patients to use the sought-after medication and could potentially broaden insurance coverage. The drug’s maker, Novo Nordisk, said it had also applied for an expanded label in the European Union.

The FDA approval was based on the results of a large study of more than 17,000 adults aged 45 and older. Researchers gave the participants injections of Wegovy or a placebo and followed them for several years. Of those who received placebo injections, 8 percent had a heart attack, stroke or died from a cardiovascular event, compared to 6.5 percent of participants who took Wegovy.

While it’s not clear whether the drug’s effect comes purely from weight loss, or whether the drug has other heart benefits, the data shows “that when you treat obesity seriously in people with a high burden of disease, you can really get good results.” reaches.” results,” said Dr. Melanie Jay, director of the NYU Langone Comprehensive Program on Obesity.

The new indication comes at a challenging time for the relatively new class of drugs that includes Wegovy and Ozempic. The drugs are highly effective, but expensive: Wegovy has a list price of more than $1,300 for about a month’s supply. And doctors typically say patients may need to take these medications for the rest of their lives. These cost considerations have led some employers and health plans to stop covering the drugs, or to restrict access or limit spending due to rising demand.

The updated label will likely increase pressure on payers and employers to cover the drugs. Many of the patients who could qualify for Wegovy under the new indication may receive Medicare, said Dr. Andrew Kraftson, clinical associate professor in the division of metabolism, endocrinology and diabetes at Michigan Medicine.

Medicare does not cover weight management medications, but could move to Wegovy for cardiovascular risk reduction, said Dr. Scott Hagan, an assistant professor of medicine at the University of Washington who has studied obesity.

And drugmakers have periodically struggled to meet demand for these drugs in recent years. Almost all Wegovy doses are in short supply, and one FDA database It is not specified how long the shortage will last.

The drug has clear benefits, said Dr. Kraftson, “but how are you going to make it available?”

A Novo Nordisk representative said that while “overall demand will continue to exceed supply,” the company will more than double the amount of lower doses of Wegovy in the U.S. market and gradually increase overall supply this year.

Because patients who would benefit from the drugs cannot get them, pharmaceutical companies have also begun to push back against consumers using the drugs for cosmetic purposes. Eli Lilly, which makes the weight-loss drug Zepbound, released a video ahead of this year’s Oscars, which chastises people who used the drugs “for the smaller dress or tuxedo, for a big night, for vanity.”

The new approval could only lead to more demand: one recently study estimated that millions of people in the United States would be eligible for the medication to prevent cardiovascular problems.

“It definitely shows great potential for this drug beyond the weight reduction,” said Dr. Yuan Lu, assistant professor of cardiovascular medicine at Yale School of Medicine and author of that study.

Many of those eligible for Wegovy under the new indication may be older adults with a history of heart disease, said Dr. Kraftson. He noted that some of the drug’s side effects — particularly the loss of muscle mass — could be particularly risky for that population.

“Are they going to lose too much weight and even become more vulnerable?” he said.

For many patients, the benefits of Wegovy may outweigh the risks, he said. But even in those cases, it can be difficult for people to get their hands on the medication.