- Lilly’s obesity pill delivered in sleep apnea. Foundayo significantly reduced the severity of obstructive sleep apnea in a late-stage trial, and Eli Lilly plans to file by the end of the year for U.S. approval of the daily pill for moderate-to-severe OSA in adults with obesity or who are overweight, CNBC reported.
- The numbers are strong for patients off PAP machines. Among 363 patients unable or unwilling to use positive airway pressure therapy, Foundayo cut apnea-hypopnea index events by an average of 21.1 per hour at 52 weeks versus 4.8 for placebo, an overall reduction of 43.8% versus 6.3%, or 37.5 percentage points placebo-adjusted by our calculation; 31.5% reached remission or mild OSA.
- It also worked alongside PAP. In 349 patients who stayed on PAP therapy, Foundayo reduced AHI events by 18.3 per hour versus 5.5 for placebo, a 27.5% overall reduction versus 3%, and patients lost roughly 11% of their weight across groups at 52 weeks.
- The market is big and underserved. OSA affects nearly 1 billion adults globally, including 80 million people ages 20 and over in the U.S., according to the National Council on Aging, and Lilly shares were up 3.5% at $1,401.04 as of 10:45 a.m. ET, according to CNBC data.
What Happened?
Lilly said Foundayo, which rolled out in the U.S. in April, met its goals in two independent studies in which patients started at a low dose and stepped up at four-week intervals. Beyond the primary AHI measure, the pill cut sleep apnea-specific hypoxic burden, a gauge of how deeply and for how long oxygen levels fall during sleep, by 55.9% in patients not on PAP and 45.8% in those using it, and lowered a marker of inflammation. Safety was generally consistent with earlier trials, though about 12% of Foundayo patients not on PAP discontinued because of side effects, versus 3.8% on placebo, and 6.8% of those on PAP stopped versus 0.6%. The most common side effects were gastrointestinal and generally mild to moderate.
Why It Matters?
An OSA label would give Lilly a second big indication for its oral GLP-1 in a condition where its injection Zepbound became the first approved medication in December 2024. A pill is a more convenient option for patients who otherwise rely on cumbersome PAP machines, and Lilly says most people with OSA have never been diagnosed, pointing to a large untapped market. For investors, the data broaden Foundayo’s commercial runway beyond weight loss, though higher dropout rates on the drug are a reminder that tolerability can limit uptake.
What’s Next?
Lilly plans to submit the results to the FDA by the end of the year. “With plans to submit these results to the FDA by the end of the year, we could have the opportunity to help people living with OSA,” said Dr. Thomas Seck of Lilly Cardiometabolic Health. Watch for full data presentations, how regulators weigh the discontinuation rates, and competition from other GLP-1 treatments that have shown promise in the condition.
Affected Tickers and Coins: LLY
Source: CNBC, CNBC Market Data
