Wegovy, the blockbuster weight loss drug, is now approved for a new use: reducing the risk of heart attacks, strokes and cardiovascular-related death in adults who have heart disease and are overweight or have obesity.
The new indication, which the Food and Drug Administration announced on 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 filed for an expanded label in the European Union.
The F.D.A. approval was based on the results of a large study of over 17,000 adults ages 45 and older. Researchers either gave participants shots of Wegovy or a placebo and followed them several years. Among those who received placebo shots, 8 percent had a heart attack, stroke or died from a cardiovascular event, compared with 6.5 percent of participants who took Wegovy.
While it’s not clear whether the effect of the drug is purely from weight loss, or whether the drug has other heart benefits, the data shows “that when you treat obesity seriously in people who have a high burden of disease, you can get really good outcomes,” said Dr. Melanie Jay, director of the N.Y.U. Langone Comprehensive Program on Obesity.
The new indication comes at a challenging moment for the relatively new class of drugs that includes Wegovy and Ozempic. The medications are highly effective, but costly: Wegovy has a list price of over $1,300 for about a month’s supply. And doctors typically say patients may need to take these drugs for the rest of their lives. Those cost considerations have led some employers and health plans to stop covering the medications, or to limit access or cap spending amid soaring demand.
The updated label will likely deepen the pressure on payers and employers to cover the drugs. Many of the patients who could qualify for Wegovy under the new indication may be on 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 cover 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 medications in recent years. Nearly all doses of Wegovy are in short supply, and an F.D.A. database does not specify how long the shortage will last.
The drug has clear benefits, Dr. Kraftson said, “but how are you going to make it available?”
A representative for Novo Nordisk said that while “overall demand will continue to exceed supply,” the company would more than double the amount of lower-strength doses of Wegovy on the United States market and gradually increase the overall supply this year.
With patients who would benefit from the medications unable to get them, drug companies have also started to push back against consumers taking the medications for cosmetic purposes. Eli Lilly, which makes the weight-loss drug Zepbound, released a video ahead of this year’s Oscars, chastising people who used the drugs “for the smaller dress or tux, for a big night, for vanity.”
The new approval may only drive more demand: One recent study estimated that millions of people in the United States would be eligible for the medication to prevent cardiovascular issues.
“It definitely demonstrates big potential for this drug, beyond the weight reduction,” said Dr. Yuan Lu, an assistant professor of cardiovascular medicine at Yale School of Medicine and an author of that study.
Many of those eligible for Wegovy under the new indication may be older adults with a history of heart disease, Dr. Kraftson said. He noted that some of the drug’s side effects — specifically, the loss of muscle mass — could be especially risky for that population.
“Are they going to lose too much weight and become actually more frail?” he said.
For many patients, the benefits of Wegovy may outweigh the risks, he said. But even in those cases, people may have a hard time getting their hands on the medication.
