The U.S. Food and Drug Administration on Wednesday gave its approval to Eli Lilly’s GLP-1 weight loss pill.
The daily pill, called Foundayo, is the second oral GLP-1 product to reach the market over the past few months, NBC News reported. It follows the release of the Wegovy pill by Novo Nordisk in December, according to CNBC.
It was the fifth approval by the FDA under the Commissioner’s National Priority Voucher (CNPV) pilot program, the agency said in a news release.
“This decision represents a historic milestone as the first new molecular entity (NME) approved under the program,” the FDA stated. “It is also the fastest approval of an NME since 2002.”
FDA approves Eli Lilly's GLP-1 pill, opening the next phase of the weight loss drug market https://t.co/862307v6Gg
— CNBC International (@CNBCi) April 1, 2026
Lilly said it will begin shipping Foundayo, from its direct-to-consumer platform LillyDirect on Monday, CNBC reported. It will be available at pharmacies and on telehealth platforms “shortly after.”
Foundayo will be offered in six doses and can be taken at any time of the day without meal restrictions, NBC News reported.
“It’s a big moment,” Lilly CEO Dave Ricks told CNBC. “We’ve obviously been working in this category of medicines for a while with the first GLP-1 medication 20 years ago and improving ever since. Here is an option that’s not more effective ... but it’s more accessible, it’s easier to fit into your daily routine.”
Consumers with insurance coverage could pay $25 a month with a coupon from Lilly, according to CNN. People who pay for the pill out of pocket could spend between $149 and $349 depending on the dosage.
Lilly said that Medicare would also cover the pill for some patients, with a monthly copayment of no more than $50, according to the cable news outlet. That could begin as soon as July 1.
“This approval demonstrates what the FDA can achieve when we eliminate delays and prioritize fast and thorough work from the agency and industry partners,” FDA Commissioner Martin Makary said in a statement. “By cutting idle time and maintaining constant communications with the company throughout the review process, we completed this national priority review with outstanding efficiency, while upholding the FDA’s gold-standard science.
“This reflects the level of performance the public should expect from the FDA.”
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