Eli Lilly announced Monday that its obesity pill Foundayo significantly reduced the severity of obstructive sleep apnea in late-stage clinical trials, positioning the medication as a potential alternative to cumbersome breathing machines for millions of Americans struggling with the dangerous sleep disorder.
Trial Results and FDA Plans
The pharmaceutical company tested Foundayo in patients with obesity who suffer from moderate-to-severe obstructive sleep apnea, a condition where breathing repeatedly stops during sleep due to blocked airways. The drugmaker plans to file for Food and Drug Administration approval by year’s end, seeking authorization for the daily pill to treat adults with obesity or who are overweight. If approved, Foundayo would join Lilly’s weight loss injection Zepbound as treatment options for the condition.
Dr. Thomas Seck, senior vice president of product development at Lilly Cardiometabolic Health, said Foundayo is already making a difference for people living with obesity. The company hopes these results will create opportunities to help people suffering from obstructive sleep apnea, a condition affecting nearly 1 billion adults worldwide.
The Sleep Apnea Challenge
Obstructive sleep apnea affects approximately 80 million Americans ages 20 and over, though most cases remain undiagnosed according to the National Council on Aging. The condition causes interrupted breathing during sleep, leading to dangerous drops in oxygen levels and increases in blood pressure. These disruptions create serious health risks including hypertension, heart failure, and stroke. Currently, patients have limited treatment options beyond medication, with many relying on positive airway pressure machines that prove cumbersome for long-term use.
Market Position and Implications
Foundayo launched in the United States in April and now joins a growing class of GLP-1 treatments showing effectiveness against sleep apnea. Lilly’s Zepbound injection became the first medication approved specifically for obstructive sleep apnea in December 2024, breaking new ground in pharmaceutical treatment for the disorder. The development of oral alternatives like Foundayo represents significant progress for patients who prefer daily pills over injectable medications or bulky breathing machines during sleep.
The trial included 363 patients in its first study, testing the pill’s effectiveness in individuals unable to tolerate or unwilling to use traditional positive airway pressure devices. This research addresses a critical gap in treatment options for Americans facing this widespread yet under-diagnosed condition that threatens cardiovascular health and overall quality of life.