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FDA approves new daily weight-loss pill from Eli Lilly

Exterior view of the headquarters of US Food and Drug Administration (FDA) Silver Spring^ MD^ USA 11-10-2020

The U.S. Food and Drug Administration has approved a new once-daily weight-loss pill from Eli Lilly, marking a significant step in the rapidly growing market for GLP-1 medications. The drug, sold as Foundayo, becomes only the second oral option available, following a similar pill from Novo Nordisk.

Unlike some competing treatments, Foundayo can be taken at any time of day without food restrictions, offering a simpler routine. As CEO Dave Ricks explained, “It’s a breakthrough in that it’s a simple oral medication… it fits into your daily routine.” Patients typically begin on a lower dose and gradually increase to minimize side effects.

Pricing is expected to range from about $149 to $349 per month for those paying out of pocket, with lower copays possible through insurance or manufacturer programs. Medicare coverage for some patients could begin as soon as this summer, potentially lowering costs further.

Demand for pill-based GLP-1 drugs is already strong. Early data from Novo Nordisk’s oral treatment suggests significant uptake, indicating these medications may attract new patients rather than simply replace injectable users.

Foundayo’s side effects are similar to other drugs in its class, most commonly involving digestive issues like nausea, constipation, and diarrhea. Despite somewhat lower effectiveness, the pill’s ease of use, broader accessibility, and lower manufacturing complexity could help it reach a wider global audience. Clinical trial results show that patients taking the highest dose lost around 12% of their body weight over roughly 72 weeks—comparable to other pills but less than injectable treatments like Zepbound. Still, the convenience of a pill may appeal to those who want to avoid injections or maintain weight loss after using them.

Looking ahead, Eli Lilly is continuing to develop additional treatments, including a more powerful experimental drug, retatrutide, as competition intensifies and options for patients continue to grow.

Editorial credit: grandbrothers / Shutterstock.com

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