The FDA has approved the use of Novo Nordisk’s popular weight-loss drug semaglutide (brand name Wegovy) to reduce the risk of certain major heart issues — a move that could make the medication accessible to more people.
Weight loss and…? Wegovy has been approved as a weight-loss treatment for people with obesity or overweight and certain other health conditions since 2021. (Previously, a different dose of the same drug was approved under the brand name Ozempic for diabetes.)
Because the drug helps people lose weight, it was reasonable to assume it may also treat problems related to carrying excess weight, such as heart issues. However, because the trials Novo Nordisk used to get the drug approved as a treatment for obesity in 2021 didn’t prove anything more than weight loss, that’s the only indication included on its label.
“It is indefensible to make it difficult for people to access medications that will directly improve their health.”
Harlan Krumholz
Normally, this wouldn’t be such a big deal — doctors prescribe meds “off-label” all the time — but the problem with Wegovy is that Medicare and some insurance providers or plans don’t cover weight-loss drugs because they’re considered “lifestyle” medications.
Even if your doctor thought Wegovy could help treat more serious health issues related to obesity, you could be stuck paying out of pocket if your plan won’t cover it — and Wegovy’s list price is $1,350 for a month’s supply. It can still run up to several hundred dollars a month, even after manufacturer discounts for those who aren’t covered.
Three years before Wegovy was even approved for weight loss, Novo Nordisk started testing its ability to treat other health conditions through SELECT, a huge phase 3 trial involving more than 17,000 people with obesity or overweight and a history of cardiovascular disease.
In November 2023, Novo Nordisk published the results of SELECT, reporting that Wegovy reduced the risk of “major adverse cardiovascular events” (MACE) — heart attacks, strokes, and death from heart disease — by 20% compared to the placebo group. Deaths from any cause were also 19% lower in the treatment group.
“The point is that these drugs are not about appearance but about health.”
What’s new? Based on those results, the FDA has now decided to update the label for Wegovy to include reducing the risk of MACE in people with the same characteristics as the SELECT trial population.
“Wegovy is now the first weight loss medication to also be approved to help prevent life-threatening cardiovascular events in adults with cardiovascular disease and either obesity or overweight,” said John Sharretts, director of the FDA’s Division of Diabetes, Lipid Disorders, and Obesity.
Looking ahead: The label change doesn’t mean Medicare and other insurers will automatically start covering Wegovy to treat cardiovascular disease, but experts predict the FDA’s decision will put pressure on them to make the med available to members.
“The evidence is that they reduce risk and save lives — and so it is indefensible to deny people access, or make it difficult for people to access, medications that will directly improve their health,” Harlan Krumholz, a cardiologist at Yale New Haven Hospital, told CNN.
“The point is that these drugs are not about appearance but about health,” continued Krumholz, who has no financial ties to Novo Nordisk. “By treating obesity, we know we can reduce cardiovascular risk, and that may be only a part of the benefits that accrue.”
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