Photo: Scott Olson / Getty Images News / Getty Images
The U.S. Food and Drug Administration (FDA) has approved a new daily weight loss pill from drugmaker Eli Lilly, marking a significant expansion of oral obesity treatment options available to Americans. The FDA cleared Foundayo through its new Commissioner's National Priority Voucher (CNPV) program, reviewing the application in just 50 days, making this the fastest approval of a new molecular entity since 2002, according to the agency.
Foundayo, known scientifically as orforglipron, works like existing injectable GLP-1 medications by mimicking a natural hormone that controls appetite and feelings of fullness. One key advantage over the Wegovy pill is flexibility: Foundayo can be taken at any time of day without food restrictions, while the Wegovy pill must be taken on an empty stomach each morning.
Foundayo will be offered in six doses, with patients typically starting on the lowest and gradually increasing to reduce side effects, which can include nausea, constipation, diarrhea, and vomiting. Between 5% and 10% of participants in clinical trials stopped treatment due to side effects.
Lilly CEO Dave Ricks praised the drug's ease of use. "It's a breakthrough in that it's a simple oral medication," Ricks said. "You just put it in that pill case in the morning, and it fits into your daily routine."
Cash-paying patients can expect to pay between $149 and $349 per month, depending on the dose. Those with commercial insurance may pay as little as $25 per month using a Lilly savings card.
Under a President Trump administration plan, Medicare could begin covering Foundayo for some patients as soon as this summer, with copays as low as $50 per month. It's unclear how many private insurers will cover the drug.
Lilly plans to begin shipping Foundayo on Monday (April 6), first through its LillyDirect consumer platform and then through U.S. retail pharmacies and telehealth providers "shortly after."
Foundayo is now the second oral glucagon-like peptide-1 (GLP-1) drug approved for obesity in recent months. The first was Novo Nordisk's Wegovy pill, which the FDA approved in December.