Lilly plans FDA filing for Foundayo in sleep apnea by year-end

Obstructive sleep apnea occurs when airways narrow or become blocked during sleep, interrupting breathing. The resulting drops in oxygen and rises in blood pressure are associated with complications including hypertension, heart failure and stroke.

The condition affects nearly 1 billion adults worldwide, including 80 million people aged 20 and over in the United States, according to the National Council on Aging. Lilly said most people with OSA have never been diagnosed. Treatment options are limited; many patients use positive airway pressure (PAP) machines to maintain normal breathing.

Lilly’s weight-loss injection Zepbound became the first medication approved in the United States for OSA, in December 2024. Foundayo launched in the U.S. in April. The new trial results make it one of several GLP-1 treatments to show promise against the condition.

“Foundayo is already making a difference for people living with obesity, and with plans to submit these results to the FDA by the end of the year, we could have the opportunity to help people living with OSA,” Dr. Thomas Seck, Lilly Cardiometabolic Health’s senior vice president of product development, said in a release.