Eli Lilly announced that its obesity medication Foundayo demonstrated significant effectiveness in reducing obstructive sleep apnea severity in a late-stage clinical trial. The pharmaceutical company intends to submit a regulatory application to the U.S. Food and Drug Administration by the end of the year seeking approval to market the daily pill for treating moderate-to-severe obstructive sleep apnea in adults with obesity or who are overweight. The drug, which became available in the U.S. market in April, would join a growing class of GLP-1 treatments showing therapeutic promise for this condition.
Obstructive sleep apnea involves recurring interruptions in breathing during sleep caused by narrowed or blocked airways. These interruptions can lead to reductions in blood oxygen levels and elevations in blood pressure, potentially resulting in serious health complications including hypertension, heart failure, and stroke. The condition affects approximately one billion adults globally, with roughly 80 million individuals ages 20 and older in the United States diagnosed with the disorder, according to the National Council on Aging. Lilly noted that the majority of affected individuals have not received a diagnosis. Foundayo would become the second medication to receive approval for this indication, following Lilly’s Zepbound injection, which became the first approved medication for obstructive sleep apnea.
The clinical trial evaluated Foundayo across two independent studies. The first study included 363 patients unable or unwilling to use positive airway pressure machines, which represent the standard non-medication treatment approach. The second study encompassed 349 patients already using PAP therapy for at least three months. In the first group, patients receiving Foundayo experienced an average reduction of 21.1 apnea-hypopnea index events per hour at 52 weeks, compared with 4.8 events for those receiving placebo. The medication achieved a 43.8% overall reduction in the apnea-hypopnea index, with 31.5% of participants meeting remission or improvement to mild obstructive sleep apnea criteria.
Patients using both Foundayo and PAP therapy showed an average reduction of 18.3 apnea-hypopnea index events per hour at 52 weeks versus 5.5 for placebo, with a 27.5% overall reduction compared to 3% for placebo. The medication also reduced oxygen deprivation measures during sleep and produced approximately 11% average weight loss across treatment groups. The most frequently reported adverse effects were gastrointestinal in nature, including nausea, diarrhea, constipation, and vomiting, generally classified as mild to moderate. Discontinuation rates due to side effects were higher in the Foundayo group not using PAP therapy at 12% compared to 3.8% for placebo, and 6.8% for those on combined therapy versus 0.6% for placebo.
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