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The Federal Drug Administration (FDA) has approved a new once-daily weight-loss pill from Eli Lilly, adding to the bevy of GLP-1 medications available in the consumer marketplace.
The drug manufacturer announced on Tuesday that the company would begin shipping orforglipron, branded as Foundayo, as soon as Monday following approval from federal regulators.
Prescribed as a once‑daily pill, Foundayo is an oral GLP‑1 medication that works similarly to injectable drugs, mimicking a natural gut hormone to suppress appetite and increase feelings of fullness.
The pill can be taken any time of day without needing food or water, according to Eli Lilly.
“We believe Foundayo can help level the playing field for those living with obesity or who are overweight and living with weight-related complications,” said David A. Ricks, chair and CEO of Eli Lilly in a statement. “As a convenient, once-daily oral pill that delivers meaningful weight loss, this is obesity care designed for the real world.”
Participants who received the highest dose of orforglipron lost an average of 25 pounds, or about 11.1 percent of their body weight, over the course of two clinical trials, the company reported. Those who received a placebo pill lost an average of 5.3 pounds, or about 2.1 percent of their body weight.
The trials also found that users saw reductions in several indicators of cardiovascular risk, including waist circumference, cholesterol levels, triglyceride levels and blood pressure, regardless of dose.
The most common side effects were nausea, constipation, diarrhea, vomiting, indigestion, stomach pain, headache, swollen belly, feeling tired, belching, heartburn, gas, and hair loss
The approval comes as the FDA has been working to speed up reviews of certain high-priority drugs. The agency’s head, Commissioner Dr. Marty Makary, told reporters on Wednesday that the review of Foundayo was completed within 50 days of the company’s application.
“We want to challenge the assumptions that it takes 10 to 12 years for a drug to come to market,” Makary said. “We believe it can be done faster, without cutting any corners on safety.”
Eli Lilly said people with insurance may be able to buy the pill for as little as $25 per month with a company savings card. Those who opt to pay without insurance coverage can get the lowest dose starting at $149 a month. The medication will be available through retail pharmacies and telehealth providers nationwide.
Foundayo is the second oral GLP-1 approved for weight loss behind Novo Nordisk’s Wegovy, which earned FDA approval in December.
The FDA issued a warning to Novo Nordisk in early March over its alleged failure to report adverse side effects, including death, in patients who took Wegovy and Ozempic.
The agency did not conclude whether any of those reported side effects were explicitly linked to use of the drug, however.
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