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

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

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The daily pill, called Foundayo, is the second oral GLP-1 to hit the market in recent months, following the approval of the new Nordisk Vigovi pill in December.

Foundio will be offered in six doses, with patients usually starting at a low dose and working their way up to minimize side effects. It can be taken at any time of the day without food restrictions – unlike Vigway pills, which must be taken every morning on an empty stomach.

The lowest dose corresponding to the Vigovi pill is expected to cost about $149 per month. Higher doses can cost up to $349 per month. It’s unclear how many private insurers will cover the drug. Under the Trump administration’s plan, Medicare could begin covering the drug for some patients as early as this summer, with copays of up to $50 a month.

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

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

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

But pill prescriptions lead to weight loss compared to weekly injections — a gap that could make them less attractive to patients.

Data from a Phase 3 clinical trial found that Foundation helped people lose 12.4% of their weight, on average, after 72 weeks at its highest dose — similar to the Vigovi pill but less than the injectable versions of Vigovi and Zipbound. These are not direct comparisons because the drugs have not been compared in a clinical trial.

Maggie Linton, 77, was part of a clinical trial for Fondue through MedStar Health in Maryland. She didn’t know for sure whether she was on the active drug or the placebo, but she lost nearly 60 pounds.

“It made a huge difference almost immediately,” she said.

Linton also saw improvements in her blood pressure and cholesterol. Once the trial ended, she gained 10 pounds back but was able to maintain most of the weight loss by staying active. Other than constipation, she experienced no side effects.

Now that the drug is approved, she wants to talk to her doctor about her return. “I’m still about 20 pounds from where I want to be.”

Dr. Judy Doshi, an endocrinologist and obesity specialist at Harvard Medical School, said many of her patients who switched from injections to the Vigovi pill complained that they weren’t losing as much weight.

“The jury is still out on what people are actually getting with these pills,” said Doshi, who is not affiliated with Lilly or Novo Nordisk. “I mean, 12% is weaker than what you see with Wegovy and Zepbound.”

Rex agreed that the zip bound was more effective but said the bullet still had a place.

“People report having great success with Zipbound and then want to transition to something, you know, a little less invasive than a weekly injection, where you have to carry it in the fridge and remember to take it once a week,” he said.

Demand for weight-loss pills is strong, if New Nordisk’s sales are any indication. In February, Novo Nordisk said more than 170,000 people had taken the Vigovi pill since it was launched in January.

Doshi said the pill may be a good option for people looking to lose weight after using injectable versions.

They may also benefit patients prone to injection site reactions.

“People really have a hard time with injections,” she said.

Lilly said the side effects of Foundave are similar to those of its injectable drugs, with gastrointestinal issues — such as nausea, constipation and diarrhea — being more commonly reported.