Eli Lilly advances Foundayo filing after late-stage sleep apnea trial results

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Eli Lilly Foundayo sleep apnea

Highlights

Eli Lilly plans FDA submission for Foundayo by year-end after late-stage trials showed up to 43.8% reduction in apnea-hypopnea index versus 6.3% for placebo.
Foundayo reduced sleep apnea-specific hypoxic burden by 55.9% in non-PAP and 45.8% in PAP users, and produced approximately 11% body weight loss at 52 weeks.
About 12% of non-PAP and 6.8% of PAP combination patients discontinued due to side effects, mainly mild-to-moderate gastrointestinal events, compared to 3.8% and 0.6% for placebo.

Trial results support planned U.S. submission

As reported by CNBC, Lilly said on Monday that Foundayo significantly reduces the severity of obstructive sleep apnea in a late-stage trial, and the drugmaker plans to file with the FDA by the end of the year for use in adults with obesity or who are overweight. The daily pill, which rolled out in the U.S. in April, adds to Lilly's push to broaden its cardiometabolic portfolio beyond weight loss alone.

In the first of two independent studies, 363 patients who were unable or unwilling to use positive airway pressure, or PAP, therapy were evaluated. In the second, 349 patients had already been using PAP therapy for at least three months at screening and continued that treatment during the trial. Patients in both studies started at a low dose and increased gradually at four-week intervals to different maximum dosages.

Researchers measured changes in the apnea-hypopnea index, or AHI, which tracks the number of hourly breathing interruptions caused by restricted or blocked airways. Among patients not using PAP therapy, those taking Foundayo recorded an average reduction of 21.1 AHI events per hour at 52 weeks, versus 4.8 for placebo, while overall AHI fell 43.8% compared with a 6.3% decrease for placebo. Lilly said 31.5% of patients in that group met criteria for remission or improvement to mild obstructive sleep apnea.

Among patients using both Foundayo and PAP therapy, the pill reduced AHI by an average of 18.3 events per hour at 52 weeks, compared with 5.5 for placebo. Overall AHI declined about 27.5% in that group, versus 3% for placebo, and 19.6% of participants met criteria for remission or mild disease.

Market implications for obesity and sleep disorder treatment

Obstructive sleep apnea is the most common sleep-related breathing disorder and 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. Lilly said most patients have never been diagnosed, underscoring the commercial opportunity for therapies that address both obesity and sleep-related breathing problems.

Lilly already has a foothold in the category after its weight loss injection Zepbound became the first medication to win U.S. approval for obstructive sleep apnea in December 2024. Outside drug treatment, many patients rely on PAP machines, which remain a standard but cumbersome option for keeping airways open during sleep.

The company said Foundayo also reduced sleep apnea-specific hypoxic burden, a measure of how deeply and how long oxygen levels fall during sleep, by 55.9% in patients not using PAP therapy and by 45.8% in those using it. Lilly added that patients lost roughly 11% of body weight across groups at 52 weeks and showed improvement in a marker of inflammation.

Safety and tolerability were generally consistent with earlier Foundayo studies, Lilly said. Discontinuation due to side effects reached about 12% among patients not using PAP therapy, compared with 3.8% for placebo, while 6.8% of those using both Foundayo and PAP stopped treatment, versus 0.6% in the placebo group. The most common side effects were gastrointestinal, including nausea, diarrhea, constipation and vomiting, and were generally mild to moderate.

Our earlier coverage of AstraZeneca’s AI drug-discovery partnership with insitro outlined a multi-year collaboration aimed at finding new targets for MASH and cardiomyopathies—areas where traditional R&D has struggled. We noted that insitro’s “Virtual Human” platform is intended to speed early discovery and help advance candidates toward the clinic, underscoring how big pharma is leaning on new tools to broaden pipelines in difficult disease areas.

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