FDA approves weight-loss drug to treat sleep apnea
The Food and Drug Administration (FDA) approved a weight-loss drug to help sleep apnea, becoming the first drug to treat the disorder affecting millions of Americans.
On Friday, the federal agency green-lighted Eli Lilly’s Zepbound drug for the use, approving a prescription medicine suited for adults suffering from moderate to severe obstructive sleep apnea (OSA) and obesity.
“Today’s approval marks the first drug treatment option for certain patients with obstructive sleep apnea,” Dr. Sally Seymour, director of the Division of Pulmonology, Allergy and Critical Care in the FDA’s Center for Drug Evaluation and Research, said in a statement. “This is a major step forward for patients with obstructive sleep apnea.”
OSA is a sleep-related breathing disorder among individuals who briefly stop breathing during sleep. There are many symptoms of OSA, including disrupted sleep, fatigue, snoring and excessive daytime sleeplessness.
"Zepbound is the first medication that significantly improves moderate-to-severe OSA and aids in long-term weight loss in adults with obesity,” the president of Lilly Cardiometabolic Health and Lilly USA Patrik Jonsson said in a statement. "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."
OSA afflicts over 25 million adults in the U.S., according to the National Healthy Sleep Awareness Project.
FDA said that Zepbound works by activating receptors of hormones to cut down on the food intake and appetite of the patients. Some studies have shown that the approved drug improves OSA with weight reduction.
The federal regulator said that Zepbound’s approval came following two placebo-controlled, randomized studies among 469 adults who did not have type 2 diabetes.