Lilly plans FDA filing for Foundayo after sleep apnea trials

Indianapolis-based Eli Lilly and Co. said Monday that its once-daily obesity pill Foundayo reduced the severity of obstructive sleep apnea in two late-stage trials. Lilly plans to ask the U.S. Food and Drug Administration by the end of 2026 to approve the drug for moderate-to-severe obstructive sleep apnea in adults with obesity or overweight.

The 52-week ATTAIN-OSA program enrolled 712 adults in two randomized trials. Lilly reported that Foundayo reduced nighttime breathing interruptions by 43.8% among participants who were not using positive airway pressure therapy and by 27.5% among those who were using the therapy.

The company said the most common adverse events were gastrointestinal and generally mild to moderate. Some participants stopped treatment because of side effects. The filing remains planned, and the FDA has not approved Foundayo for sleep apnea.

For Lilly, the results could add another use for a drug already sold for obesity. Any expanded label will depend on the FDA's review of the application and supporting evidence.

Source note: BusinessIndy prepared this concise report from Lilly's Nov. 9 announcement and readable independent reporting. Trial results are company-reported and the FDA filing is a stated plan.

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