Eli Lilly to seek FDA approval for Foundayo as oral treatment for obstructive sleep apnea
Eli Lilly announced positive Phase 3 ATTAIN-OSA results showing its oral GLP‑1 pill Foundayo reduced apnea‑hypopnea index events by 43.8% in participants not using PAP therapy and by 27.5% in those using PAP therapy after 52 weeks. The trial also produced average weight loss of about 28 lb (≈11% of body weight) and lowered systolic blood pressure by 7.5 mmHg versus 1.7 mmHg with placebo in the non‑PAP group. Lilly plans to file an FDA submission for the sleep‑apnea indication by the end of 2026.
Why it matters
The company’s filing plan could add a new, daily‑pill indication to its already approved obesity product, expanding the market addressable to patients with moderate‑to‑severe OSA. If approved, the oral therapy would compete with the injectable Zepbound, potentially shifting prescribing patterns and insurance coverage for sleep‑apnea treatment.
Key facts
- 1Foundayo reduced AHI events by 21.1 per hour (43.8%) in non‑PAP participants after 52 weeks, from a baseline of 50.7 events per hour. prnewswire.com
- 2Foundayo reduced AHI events by 18.3 per hour (27.5%) in PAP participants after 52 weeks, from a baseline of 57.6 events per hour. prnewswire.com
- 331.5% of non‑PAP participants achieved remission or mild disease after treatment. prnewswire.com
- 419.6% of PAP participants achieved remission or mild disease after treatment. prnewswire.com
- 5Participants lost an average of 28.0 lb (11.5%) without PAP and 28.2 lb (11.2%) with PAP. prnewswire.com
- 6Systolic blood pressure fell 7.5 mmHg with Foundyo versus 1.7 mmHg with placebo in the non‑PAP group. medicaldaily.com
Summary written by AlphAI AI Desk from 17 of 17 sources. Not investment advice. Figures are as stated by the linked sources.