The U.S. Food and Drug Administration has approved Eli Lilly’s GLP-1 weight loss pill, Foundayo. This daily pill is the second oral GLP-1 product on the market in recent months, following Novo Nordisk’s Wegovy pill in December. Foundayo is the fifth approval made under the FDA’s Commissioner’s National Priority Voucher (CNPV) pilot program, marking a historic milestone as the first new molecular entity (NME) approved under the program and the fastest approval of an NME since 2002.
Lilly will start shipping Foundayo through its direct-to-consumer platform LillyDirect on Monday, available in pharmacies and on telehealth platforms shortly after. The pill comes in six doses and can be taken at any time of the day without meal restrictions.
Lilly CEO Dave Ricks stated, “It’s a big moment. We’ve been working in this category of medicines for 20 years and improving ever since. Foundayo is not more effective but more accessible and easier to fit into your daily routine.”
Consumers with insurance coverage can pay $25 a month with a coupon from Lilly, while those paying out of pocket may spend between $149 and $349 depending on the dosage. Medicare will also cover the pill for some patients with a monthly copayment of no more than $50, starting as soon as July 1.
FDA Commissioner Martin Makary emphasized the efficiency of the approval process, stating, “This approval demonstrates what the FDA can achieve when we eliminate delays and prioritize fast and thorough work. By maintaining constant communication throughout the review process, we completed this national priority review with outstanding efficiency, upholding the FDA’s gold-standard science.”
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