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The FDA has approved the use of Novo Nordisk’s popular weight loss drug semaglutide (brand name Wigovy) to reduce the risk of certain serious heart conditions. This could make the drug available to more people.
Weight loss…? Wegovy has been approved as a weight loss treatment for people with obesity or overweight and certain other health conditions starting in 2021. (Previously, a different dose of the same drug was approved for diabetes under the brand name Ozempic).
Since this drug helps you lose weight, it is reasonable to think that it may also treat problems associated with excess weight, such as heart problems. But trials conducted by Novo Nordisk to approve the drug as a treatment for obesity in 2021 showed no benefit beyond weight loss, so that’s the only indication listed on the label.
“It is indefensible to make it harder for people to access medicines that directly improve their health.”
Harlan Krumholtz
Usually this isn’t that big of a deal. Doctors prescribe drugs “off-label” all the time. But the problem with Wegovy is that Medicare and some insurance companies and insurance plans don’t cover weight loss drugs. It is considered a “lifestyle” drug.
Even if your doctor thinks Wegovy can help treat more serious health problems related to obesity, you could end up paying out of pocket if your plan doesn’t cover it. Also, Wegovy’s list price is $1,350 for one month. Even after manufacturer discounts for people who don’t qualify, it can cost up to several hundred dollars a month.
Three years before Wegovy was approved as a weight loss drug, Novo Nordisk was testing its ability to treat other health conditions through SELECT, a large Phase 3 trial involving more than 17,000 people who were obese or overweight. The test has started. and History of cardiovascular disease.
In November 2023, Novo Nordisk announced the results of SELECT, showing that Wegovy reduced the risk of “major cardiovascular events” (MACE) (heart attack, stroke, and death from heart disease) by 20% compared to the placebo group. reported to have decreased. All-cause mortality was also reduced by 19% in the treatment group.
what’s new? Based on these results, FDA has now decided to update Wegovy’s label to include reducing the risk of MACE in people with the same characteristics as the SELECT study population.
“Wegovy can also be used to prevent life-threatening cardiovascular events in obese or overweight adults with cardiovascular disease,” said John Sharetz, director of the FDA’s Division of Diabetes, Dyslipidemia, and Obesity. “This is the first approved weight-loss drug.” .
Future prospects: Although the label change does not mean Medicare and other insurance companies will automatically begin covering Wegovy for the treatment of cardiovascular disease, experts say the FDA’s decision may We predict that there will be pressure to provide this.
“The evidence is that medicines reduce risk and save lives. It is therefore indefensible to deny people access to or make it difficult for people to access medicines that directly improve their health. ” said Harlan Krumholz, a cardiologist at Yale New Haven Hospital. he told CNN.
“The important thing is that these drugs are for health, not appearance,” continued Krumholz, who has no financial ties to Novo Nordisk. “We know that treating obesity can reduce cardiovascular risk, but that may only be part of the benefit.”
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