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Foundayo FDA Approved: Flexible GLP-1 Weight Loss Pill

The FDA approved Foundayo, Eli Lilly's GLP-1 weight loss pill, in March 2025. It offers flexible dosing without food restrictions, unlike Wegovy. Pricing starts at $149 monthly out-of-pocket, with insurance options including Medicare. Clinical trials showed 12% average weight loss over 72 weeks, with side effects like nausea and constipation. The drug is for adults only and will be available from April via LillyDirect.

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Foundayo FDA Approved: Flexible GLP-1 Weight Loss Pill

The FDA has approved Foundayo (orforglipron), Eli Lilly's second GLP-1 weight loss pill, offering more flexible dosing compared to competitors.

FDA Approval and Background

  • The US Food and Drug Administration approved Foundayo in March 2025 for the treatment of obesity.
  • It is the second GLP-1 pill on the market, following Novo Nordisk's Wegovy pill.
  • Eli Lilly, the manufacturer, also markets GLP-1 drugs Zepbound for obesity and Mounjaro for diabetes.

Key Advantages Over Wegovy

  • Foundayo can be taken at any time of day without restrictions on food or water intake.
  • In contrast, the Wegovy pill must be taken 30 minutes before food or drink in the morning.
  • Lilly designed the pill to integrate easily into patients' daily routines.
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Pricing and Insurance Coverage

  • Out-of-pocket costs start at $149 per month for the lowest dose and go up to $399 for the highest dose.
  • Patients with commercial insurance can use a coupon to pay $25 per month.
  • Medicare coverage begins as early as July 1 with a copay of no more than $50 per month.
  • These pricing structures are part of an agreement with the Trump administration to improve access.

Efficacy and Side Effects

  • In clinical trials, participants on the highest dose lost an average of 12% of body weight over 72 weeks, compared to 0.9% for the placebo group.
  • Common side effects include nausea, constipation, and hair loss, similar to other GLP-1 drugs.
  • The drug is approved for adults only; safety and efficacy have not been established in children or during pregnancy.
  • Women on birth control should consult doctors as Foundayo may reduce contraceptive effectiveness.

Availability and Future Outlook

  • Foundayo will be available for free home shipping via LillyDirect starting April 6, 2025.
  • Broader availability through pharmacies and telehealth providers is expected shortly after.
  • Novo Nordisk has introduced subscription pricing for Wegovy, ranging from $249 to $329 per month.
  • Lilly aims to expand obesity treatment access to more Americans.
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