FDA approves GLP-1 weight loss pill Foundayo from Eli Lilly

The Food and Drug Administration on Wednesday approved a new weight loss pill from drugmaker Eli Lilly.

The daily pill, called Foundayo, is the second oral GLP-1 to reach the market in recent months, following the approval of Novo Nordisk’s Wegovy pill in December.

Foundayo will be offered in six doses, with patients typically starting on the lowest dose and working their way up to reduce side effects. It can be taken at any time of day without meal restrictions — unlike the Wegovy pill, which must be taken on an empty stomach each morning.

The lowest dose is expected to cost about $149 a month for people paying out of pocket, in line with the Wegovy pill, while higher doses could cost as much as $399, according to Lilly. It’s unclear how many private insurers will cover the drug. Under a Trump administration plan, Medicare could begin covering the drug for some patients as soon as this summer, with copays as low as $50 a month.

“It’s a breakthrough in that it’s a simple oral medication,” Eli Lilly CEO Dave Ricks said in an interview. “You just put it in that pill case in the morning, and it fits into your daily routine.”

The approval comes as the GLP-1 market continues to expand, with newer options offering more weight loss, different forms or lower prices.

Lilly also has another GLP-1 drug in development, called retatrutide, which has shown greater weight loss in trials than any other drug on the market.

But the pill versions tend to lead to less weight loss than the weekly injections — a gap that could make them less appealing to patients.

Phase 3 clinical trial data found that Foundayo helped people lose 12.4% of their weight, on average, at its highest dose after 72 weeks — similar to the Wegovy pill but less than injectable versions of Wegovy and Zepbound. Those aren’t direct comparisons because the drugs weren’t compared in a head-to-head clinical trial.

Dr. Jody Dushay, an endocrinologist and obesity expert at Harvard Medical School, said many of her patients who have switched from injections to the Wegovy pill have complained they don’t lose that much weight.

“The jury is still out in terms of what people are really going to achieve with these pills,” said Dushay, who isn’t affiliated with Lilly or Novo Nordisk. “I mean, 12% is weak compared to what you’re going to see with Wegovy and Zepbound.”

Ricks acknowledged that Zepbound is more effective but said pills still have a place.

“People report being very successful on Zepbound and then wanting to transition to something, you know, something less invasive than a weekly injection, where you have to transport it under refrigerated conditions and remember to take it once a week,” he said.

Demand for weight loss pills is strong, if Novo Nordisk’s sales are any indication. In February, Novo Nordisk said more than 170,000 people were taking the Wegovy pill after it launched in January.

Dushay said the pills may be a good option for people looking to maintain weight loss after using injectable versions.

They may also benefit patients who are prone to injection site reactions.

“People really do have difficulty with injections,” she said.

Lilly said the side effects of Foundayo were similar to its injectable drugs, with gastrointestinal issues — such as nausea, constipation and diarrhea — among those most commonly reported.

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