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FDA Clears Eli Lilly’s Foundayo Oral GLP-1 for Weight Loss, With U.S. Launch Set for April 6

The move positions Lilly to challenge Novo Nordisk by pairing a more flexible pill with a rapid LillyDirect rollout and aggressive self-pay pricing.

Overview

  • Eli Lilly’s Foundayo pill, approved by the FDA on Wednesday, begins shipping Monday through LillyDirect with retail pharmacy access to follow.
  • Foundayo is a nonpeptide GLP-1 small molecule that can be taken any time of day with or without food, unlike Wegovy’s pill, which requires morning fasting and water-only dosing.
  • Lilly set costs as low as $25 per month with commercial insurance, $149 to $349 for self-pay depending on dose, and a potential $50 Medicare copay starting July 1, though broader coverage remains uncertain.
  • Company data show about 12% average weight loss over roughly 72 weeks, with common gastrointestinal side effects and label warnings that include a thyroid tumor risk, while injectables like Zepbound typically show greater average weight loss.
  • The approval used the FDA commissioner’s voucher pathway that has drawn scrutiny, as the new pill enters a head-to-head market fight with Novo Nordisk’s Wegovy tablets.