US regulators on Friday approved the first drug treatment for sleep apnea, permitting the use of a weight-loss medication for the condition that affects millions of Americans.
"This is a major step forward for patients with obstructive sleep apnea," US Food and Drugs Administration official Sally Seymour said in a statement announcing approval of Zepbound to treat moderate to severe sleep apnea in obese patients.
Zepbound, from drugmaker Eli Lilly, is already approved for people who are obese or overweight and have a related health condition, such as type 2 diabetes, high cholesterol or high blood pressure.
"Zepbound works by activating receptors of hormones secreted from the intestine... to reduce appetite and food intake. By reducing body weight, studies show that Zepbound also improves OSA," an FDA statement said.
Obstructive sleep apnea (OSA) is a dangerous condition in which breathing stops intermittently while a person sleeps.
Sufferers wake up repeatedly during the night because of a blocked airway, preventing them from reaching the deep, refreshing stages of slumber.
The condition is linked to higher risk of high blood pressure, stroke and depression.
Sleep apnea affects approximately 30 million adults in the United States, according to the American Academy of Sleep Medicine.
The FDA approval allows Zepbound to be used to treat "moderate to severe OSA in adults with obesity."
Until now, treatments typically involve CPAP machines, which deliver a continuous stream of air through a mask to keep the user's airways open. Surgery is also an option.
Two clinical trials showed Zepbound reduced the frequency of sleep apnea episodes, an improvement likely linked to patients' weight loss, the FDA said.
"Nearly half of clinical trial patients saw such improvements that they no longer had symptoms associated with OSA, marking a critical step forward in reducing the burden of this disease and its interconnected health challenges," said Patrik Jonsson, a senior executive at Eli Lilly, in a statement.
Zepbound, which is administered by injection once a week, should be combined with exercise and a reduced-calorie diet, the FDA said.
The medication is part of a new generation of drugs that combat obesity and related conditions by mimicking the function of a hormone that secretes insulin, slows down the emptying of the stomach, and suppresses appetite.
It includes Novo Nordisk's Ozempic, which was approved in the United States in 2017 and has since become a popular prescription drug.
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