FDA clears use of Novo’s obesity drug to protect heart health

2024-03-08

临床结果上市批准

The Food and Drug Administration has expanded the label for Novo Nordisk’s fast-selling weight loss drug Wegovy following study results that proved the medicine can protect heart health.

The agency on Friday approved use of Wegovy to reduce the risk of heart attacks, strokes or death in people with cardiovascular disease and who are either obese or overweight. The drug should be used alongside exercise and a reduced-calorie diet, the agency said.

Wegovy, part of a popular class of medicines that control blood sugar and appetite, is already approved for use in treating obesity. The drug generated about $4.5 billion in sales in 2023 despite manufacturing issues that made it difficult for the company to meet surging demand.

But Wegovy faces competition from Zepbound, a similar type of medicine developed by Eli Lilly that was cleared by the FDA last year for weight loss. Novo is also trying to stay ahead of a large group of competitors vying for a place treating obesity, a market Wall Street analysts believe could surpass $100 billion by the end of the decade.

The FDA clearance issued Friday is one step in that direction. It was based on the results of a large study, the results of which were published in The New England Journal of Medicine last year, showing that treatment with Wegovy reduced the risk of heart attack, stroke or cardiovascular death by 20% compared to a placebo.

That result put Wegovy on the “list of established therapies that form the basis of our pharmacologic strategies for reducing the risk of cardiovascular disease” Amit Khera of the University of Texas Southwestern Medical Center and Tiffany M. Powell‑Wiley of the National Heart, Lung, and Blood Institute wrote in an NEJM editorial at the time.

The findings separate Wegovy from Lilly’s rival medicines, at least for now. Results could come from a similar type of trial of Lilly’s Mounjaro, a version of Zepbound sold for Type 2 diabetes, later this year. A study of Zepbound could follow a few years later.

The results could also spur broader use of Wegovy, as such evidence can help sway insurers to cover treatment. Many payers have been hesitant to widely cover drugs like Wegovy, and Medicare is prohibited by law from doing so.

“We definitely know these drugs work for weight loss,” Martha Gulati, director of preventive cardiology at Cedars-Sinai Medical Center, said in an interview last year. “In terms of accessing these medications, it’s quite the challenge. We do need to convince the insurers.”

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