On Friday, the U.S. Food and Drug Administration approved Eli Lilly’s weight loss treatment for obstructive sleep apnea, Zepbound, making it the first drug to get the green light to directly treat patients with the common sleep disorder, as That has been reported by Reuters.
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“Regulators have approved the drug for moderate to severe obstructive sleep apnea in adults with obesity,” the company said.
The approval opens up a larger patient market for Lilly as demand for Zepbound continues to grow. It could also strengthen Lilly’s position with commercial insurers and employers, who have been reluctant to cover the drug because of its high price. Following the announcement, shares of the Indianapolis-based drugmaker rose 1.14% in after-market trading.
What happens in sleep apnea?
Reuters reported that sleep apnea patients stop breathing for brief periods while sleeping, which disrupts sleep cycles and leads to long-term complications such as heart conditions. The condition affects approximately one billion people globally.
“Too often, obstructive sleep apnea is dismissed as ‘just snoring’ — but it’s much more than that,” said Julie Flygare, CEO of the nonprofit organization Project Sleep.
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Common treatments for sleep apnea include CPAP machines (which require wearing a mask while sleeping), surgery, and weight loss. Zepbound, along with Lilly’s popular diabetes drug Monjaro, both contain tirazeptide, a GLP-1 agonist. These medications, initially developed for type 2 diabetes, also help reduce food cravings and slow the emptying of the stomach.
US-based Lilly and Danish competitor Novo Nordisk are exploring additional uses for their groundbreaking obesity drugs as they compete to demonstrate their broader health benefits.
Regulators may expand approval for drugs if new data shows them effective in other therapeutic areas.
The FDA approval is based on data from two trials involving 469 participants, in which Zepbound helped reduce breathing difficulties in patients with moderate to severe obstructive sleep apnea.
The drugmaker published full data in June, which showed the drug helped resolve the disorder in 52% of patients in these trials, Reuters reports.
(With inputs from Reuters)
