Author: Bhanvi Satiya
(Reuters) – The U.S. Food and Drug Administration on Friday approved Eli Lilly’s (NYSE:) weight loss drug Zepbound for obstructive sleep apnea, making it the first drug to get the green lightweight to directly treat patients with the common sleep disorder.
Regulatory approval of the drug for the treatment of moderate to severe obstructive sleep apnea in adults with obesity, the company said.
The approval opens up a broad patient market for Lilly at a time when demand for Zepbound is already growing.
It could also strengthen Lilly’s case with commercial insurers and employers who have previously been hesitant to cover the drug because of its high cost.
Shares of the Indianapolis-based drugmaker rose 1.14% after the announcement.
Patients with sleep apnea stop breathing briefly during sleep, disrupting their sleep cycle and causing long-term complications such as heart disease. This disease affects approximately one billion people around the world.
“Too often, obstructive sleep apnea is dismissed as ‘just snoring’ – but it is much more than that,” said Julie Flygare, CEO of the nonprofit Project Sleep.
Common treatments for this condition include CPAP machines, which include wearing a face mask while sleeping, surgery, and weight loss.
A widely used diabetes drug from Zepbound and Lilly, Mounjaro, both chemically called tirzepatid, belongs to a class of drugs called GLP-1 agonists.
Originally developed for type 2 diabetes, they also reduce appetite and cause the stomach to empty more slowly.
US-based Lilly and Danish rival Novo Nordisk (NYSE:) are testing their blockbuster obesity drugs for a range of conditions as they race to show they have other health benefits.
Regulators may expand drug approvals if modern data shows they are effective in other therapeutic areas.
The FDA approval is based on data from two studies involving 469 participants in which Zepbound helped alleviate breathing difficulties in patients with moderate to severe obstructive sleep apnea.
The drugmaker released full data in June showing that the drug helped treat the disease in up to 52% of patients in those trials.
The study data also showed that Zepbound reduced the so-called biomarkers of sleep apnea, including low blood oxygen levels and blood pressure, which may indicate heart disease.
Government-backed Medicare plans for adults 65 and older and people with disabilities cannot cover weight loss treatments, although the Biden administration has proposed expanding coverage of anti-obesity medications.
If the modern administration of President-elect Donald Trump supports this move, the program will take effect in 2026.
Medicare began funding Novo Nordisk’s Wegova only after it received approval in March to reduce the risk of heart attacks and strokes.
