Eli Lilly's Foundayo met primary endpoints in the ATTAIN-OSA trial, showing significant reductions in sleep apnea severity and body weight, with an FDA submission planned by year-end 2026.
Lilly's oral GLP-1 Foundayo met the primary endpoint in the Phase 3 ATTAIN-OSA trial, cutting AHI by up to 43.8% and body weight by ~11.5% at 52 weeks, with an FDA submission for OSA planned by end of 2026. A new indication for a pill already approved for obesity expands the addressable market of 936 million adults with OSA. The result was largely anticipated given earlier program success, so the move should be supportive but not dramatic.
Eli Lilly and Company announced positive Phase 3 results for Foundayo (orforglipron) in treating moderate-to-severe obstructive sleep apnea. The trial demonstrated a 43.8% reduction in breathing interruptions for patients not using PAP therapy and an 11.5% average body weight loss at 52 weeks. Lilly plans to submit the data to the U.S. FDA for regulatory approval by the end of 2026.
At 52 weeks, Foundayo reduced breathing interruptions (AHI) by 43.8% in patients not using PAP therapy and 27.5% in those using it, with 31.5% of the non-PAP group reaching remission or mild disease, alongside roughly 11.5% weight loss.
Lilly plans to submit the data to the U.S. FDA for moderate-to-severe obstructive sleep apnea in adults with obesity or overweight by the end of 2026, with other global submissions to follow.