Wegovy Approved in U.S. to Reduce Risk of Heart Attacks, Strokes
Mar 28, 2024
The
U.S. Food and Drug Administration approved a new use for Novo Nordisk’s popular
anti-obesity drug Wegovy: protecting heart health.
The agency’s approval on Friday
means that Novo Nordisk may now promote the drug’s ability to reduce a person’s
risk of heart attacks and strokes in people with obesity and a history of heart
disease, as a large study showed last year.
That added benefit could help
ratchet up pressure on U.S. insurers and employers to begin covering Wegovy,
making it more affordable for people facing a list price of $1,349 a month.
Many employers have been reluctant to begin
covering weight-loss drugs–or have pulled back on
it–because of cost and other factors. Drugmakers including Novo Nordisk and Eli
Lilly, which sells the new anti-obesity drug Zepbound, have been trying to
demonstrate added benefits beyond shedding pounds in studies, partly to
persuade insurers that they’re worth paying for.
“This approval represents a
paradigm shift in obesity treatment and payer coverage, as GLP1 therapies will
now be seen as providing benefit beyond weight, now including prevention of”
cardiovascular events, BMO Capital Markets analyst Evan Seigerman wrote in a
research note. “In other words Wegovy can be used on label to prevent a heart
attack.”
A study of more than 17,000
patients who were obese or overweight, and had a history of cardiovascular
disease, found that taking Wegovy not only helped them lose weight but also reduced the risk of
heart attacks, strokes and cardiovascular deaths by 20%.
Some 6.5% of Wegovy patients
experienced those events, compared with 8% in the placebo group.
“This patient population has a
higher risk of cardiovascular death, heart attack and stroke. Providing a
treatment option that is proven to lower this cardiovascular risk is a major
advance for public health,” said John Sharretts, director of the FDA’s division
evaluating obesity drugs.
Novo also hopes the new FDA
approval keeps it competitive against Lilly, whose Zepbound drug has
demonstrated higher weight loss in studies. Lilly, however, hasn’t yet
completed a study of Zepbound’s effect on heart health, so it can’t currently
claim that benefit to doctors and insurers.
"We are very pleased that
Wegovy is now approved in the U.S. as the first therapy to help people manage
their weight and reduce cardiovascular risks," said Martin Holst Lange,
executive vice president and head of development at Novo Nordisk.
Source: Wall Street Journal