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# Lilly’s Files Mounjara NDA for Sleep Apnea
- URL: https://www.fdaweb.com/lillys-files-mounjara-nda-for-sleep-apnea/
- Published: 2024-06-21T12:00:00.000Z
- Updated: 2026-09-14T14:33:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157231

Eli Lilly says it has submitted an NDA for weight loss therapy Mounjaro (tirzepatide) for treating moderate-to-severe obstructive sleep apnea (OSA) and obesity, and it expects a regulatory decision by the end of the year.

The submission is based on data from the SURMOUNT-OSA Phase 3 clinical trials evaluating tirzepatide injection (10 mg or 15 mg) for treating moderate-to-severe OSA in adults with obesity, with and without positive airway pressure therapy. “In both studies,” the company says, “tirzepatide achieved all primary and key secondary endpoints for both the efficacy and treatment-regimen estimands and demonstrated a mean reduction of up to 62.8% on the apnea-hypopnea index, or about 30 fewer events restricting or blocking a person's airflow per hour of sleep, compared to placebo.”

Regarding safety, Lilly says the overall safety profile of tirzepatide in SURMOUNT-OSA studies was similar to previously reported trials. “The most commonly reported adverse events in SURMOUNT-OSA were gastrointestinal related and generally mild to moderate in severity,” it says. “The most frequent events reported by those on tirzepatide compared with placebo, respectively, were diarrhea (26.3% vs 12.5%), nausea (25.4% vs 10.0%) and vomiting (17.5% vs 4.2%) in SURMOUNT-OSA Study 1, and diarrhea (21.8% vs 8.8%), nausea (21.8% vs 5.3%) and constipation (15.1% vs 4.4%) in SURMOUNT-OSA Study 2.”