The Food and Drug Administration on Monday approved the first oral medication to treat obesity, clearing a once-daily pill after clinical trials showed significant weight loss and cardiovascular benefit, drugmaker Novo Nordisk said.
The Wegovy pill contains semaglutide, the same active ingredient used in the company's injectable Wegovy and Ozempic products. It is the first oral GLP-1 receptor agonist approved in the U.S. for chronic weight management.
The FDA approved the pill for adults with obesity, or those who are overweight with at least one weight-related condition, such as heart disease, when used alongside diet and exercise.
In the pivotal OASIS 4 phase 3 clinical trial, patients taking a 25-milligram pill once daily lost an average of 16.6% of their body weight over 68 weeks, compared with 2.7% for those receiving a placebo. About one-third of patients lost at least 20% of their body weight, according to Novo Nordisk.
The company said the approval is also supported by data from the large SELECT trial, which found semaglutide reduced the risk of major adverse cardiovascular events, including heart attack and stroke, in adults with established cardiovascular disease and obesity or overweight.
Until now, FDA-approved GLP-1 drugs for weight loss have required injections. GLP-1 medications work by mimicking a hormone that regulates appetite and slows digestion, helping patients feel full longer.
"With today's approval of the Wegovy pill, patients will have a convenient, once-daily pill that can help them lose as much weight as the original Wegovy injection," Mike Doustdar, president and CEO of Novo Nordisk, said in a news release. "As the first oral GLP-1 treatment for people living with overweight or obesity, the Wegovy pill provides patients with a new, convenient treatment option that can help patients start or continue their weight-loss journey."
Novo Nordisk has suggested an initial U.S. launch price of about $149 for a month's worth of once-daily pills, a level substantially below many injectable GLP-1 therapies, which can cost uninsured patients hundreds of dollars a month.
The company has said oral medications might be easier for insurers to cover than injectables, potentially expanding access to patients who have avoided injections or faced coverage limits.
Novo Nordisk shares rose more than 9% in after-hours trading following the FDA approval, as investors reacted to the company's first-to-market position in oral obesity treatment.
Novo Nordisk said it expects to launch the Wegovy pill in the U.S. in early January. The company said it also has submitted the drug for regulatory review in Europe and other markets.
The approval came as Eli Lilly and Company advanced its own oral weight-loss candidate, orforglipron, which is also designed as a once-daily pill.
In late-stage trials, Eli Lilly has said orforglipron produced double-digit percentage weight loss at higher doses and met key study endpoints. The company is expected to seek FDA approval next year, setting up direct competition in what analysts project will become a multi-billion-dollar global obesity drug market.
As with other semaglutide products, the Wegovy pill carries warnings about gastrointestinal side effects and includes a boxed warning related to thyroid tumors observed in animal studies.
Michael Katz ✉
Michael Katz is a Newsmax reporter with more than 30 years of experience reporting and editing on news, culture, and politics.
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