Wegovy, the blockbuster weight loss drug, has been approved for a new use: reducing the risk of heart attack, stroke, and cardiovascular-related death in overweight or obese adults with heart disease.

The new indication, announced Friday by the Food and Drug Administration, could pave the way for even more patients to use the popular drug and expand insurance coverage. The drug’s manufacturer, Novo, said Nordisk had also applied to expand its label in the European Union.

The FDA’s approval was based on the results of a large study of more than 17,000 adults ages 45 and older. Researchers gave participants either the Wegovy shot or a placebo and followed them for several years. Among participants who received the placebo injection, 8% had a heart attack, stroke, or died from a cardiovascular event, compared with 6.5% of participants who took Wegovy.

It’s not clear whether the drug’s effects are purely due to weight loss or if it has other effects on the heart, but the data show that “when seriously treating obesity in people with severe disease, “This shows that symptoms can be significantly improved,” said Dr. Melanie Jay, director of the New York University Langone Obesity Comprehensive Program.

The new indication comes at a difficult time for relatively new classes of drugs such as Wigovy and Ozempic. These drugs are very effective, but expensive. Wegovy’s list price is over $1,300 for about a month’s supply. And doctors usually say patients may need to take these drugs for the rest of their lives. Given these costs, some employers and health insurance companies are no longer covering drugs, or are restricting access or capping spending as demand soars.

The label updates are likely to put even more pressure on payers and employers to protect medicines. Dr. Andrew Craftson, a clinical associate professor in the Department of Metabolism, Endocrinology and Diabetes at the University of Michigan Medical School, said many of the patients who may be eligible for Wegoby under the new indication are likely on Medicare. He said that there is a sex.

Dr. Scott Hagan, an assistant professor of medicine at the University of Washington who studies obesity, said Medicare does not cover weight management drugs, but could move toward covering Wegoby for cardiovascular risk reduction. .

And pharmaceutical companies have regularly struggled to meet demand for these drugs in recent years. Nearly all doses of Wegovy are in short supply, and the FDA’s database does not specify how long the shortage will last.

The drug has clear benefits, Dr. Craftson says, “but how are we going to make it available?”

A representative for Novo Nordisk said that while “overall demand will continue to outstrip supply,” the company has more than doubled the amount of low-dose Wegovy in the U.S. market and is gradually increasing its overall supply this year. He said he intends to increase it.

Pharmaceutical companies are also starting to push back against consumers who take drugs for cosmetic purposes, as patients who would benefit from them are unable to access them. Eli Lilly, the maker of the weight-loss drug Zepbound, released a video ahead of this year’s Oscars accusing people of using the drug “for a small dress or a tuxedo, for a big night, for a show.” did.

New approvals could further increase demand. Recent studies estimate that millions of people in the United States are eligible for drugs to prevent cardiovascular disease.

“Beyond weight loss, this drug clearly shows great potential,” said Yuan Lu, Ph.D., assistant professor of cardiovascular medicine at Yale School of Medicine and author of the study. Ta.

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

“Will I lose so much weight that I’ll actually become even more frail?” he said.

For many patients, the benefits of Wegovy may outweigh the risks, he said. But even in such cases, people may have difficulty obtaining the drug.