WASHINGTON — The U.S. Food and Drug Administration on Friday approved Eli Lilly's weight-loss treatment, Zepbound, for obstructive sleep apnea, making it the first drug to gain approval for directly treating this common sleep disorder.
The FDA sanctioned the drug for adults with moderate to severe obstructive sleep apnea who also suffer from obesity. This pivotal approval opens up a substantial market for Lilly, particularly as demand for Zepbound is already surging. The new indication may also strengthen Lilly's negotiating position with commercial insurers and employers, who have historically been reluctant to cover the high costs associated with the medication.
Shares of Eli Lilly, based in Indianapolis, rose by 1.14% in after-market trading following the announcement. Sleep apnea, characterized by temporary cessation of breathing during sleep, can disrupt the sleep-wake cycles and lead to long-term health complications, including serious heart conditions. Notably, it is estimated to affect approximately one billion people globally.
“Too often, obstructive sleep apnea is brushed off as 'just snoring' — but it's far more than than,” said Julie Flygare, the CEO of the nonprofit organization Project Sleep, underscoring the severity of the condition. Existing treatments for sleep apnea typically include the use of CPAP machines—devices requiring patients to wear masks during sleep, among other measures like surgery or weight loss.
Zepbound belongs to the class of drugs known as GLP-1 agonists, which includes another widely recognized diabetes medication, Mounjaro. Although initially developed to manage Type 2 diabetes, studies have revealed its efficacy in reducing food cravings and slowing gastric emptying as well.
Both U.S.-based Eli Lilly and its Danish competitor, Novo Nordisk, are engaged in extensive research and testing of their respective obesity medications for various health benefits, racing to demonstrate additional therapeutic applications. Regulators can extend the approvals of medications if new evidence supports their effectiveness across different conditions.
The FDA's decision was informed by data from two clinical trials involving 469 participants, wherein Zepbound significantly alleviated breathing difficulties associated with moderate to severe obstructive sleep apnea. Notably, results published earlier this year indicated the drug resolved sleep apnea in up to 52% of trial participants.
The trials also recorded improvements in biomarkers related to sleep apnea, such as low blood oxygen levels and elevated blood pressure, both of which can signal heart disease risks. These findings are particularly relevant considering the link between sleep apnea and heightened cardiovascular complications.
While government-backed Medicare plans for older adults and individuals with disabilities currently preclude coverage for weight-loss treatments, the Biden administration is advocating for changes to extend coverage for anti-obesity medications. This proposal, if endorsed by the incoming administration of President-elect Donald Trump, could enable Medicare to start covering such treatments by 2026.
It is noteworthy how Medicare began covering Novo Nordisk's Wegovy only after it was approved for reducing the risk of heart attacks and strokes earlier this year, reflecting broader trends within health policy and insurance coverage.
With the approval of Zepbound, Eli Lilly is poised to enter the treatment space for obstructive sleep apnea, combining traditional weight-loss approaches with innovative pharmacological solutions. This strategic positioning could signal important shifts within the obesity and sleep treatment markets and support numerous patients worldwide affected by these conditions.
