This groundbreaking decision allows the drug to be prescribed to obese adults with moderate to severe OSA, in combination with a calorie-restricted diet and increased physical activity.
The FDA has approved the weight-loss drug Zepbound, manufactured by Eli Lilly & Co. as the first prescription medication to treat obstructive sleep apnea (OSA). This groundbreaking decision allows the drug to be prescribed to adults with obesity and moderate to severe OSA, in combination with a calorie-restricted diet and increased physical activity.
OSA, a condition characterized by impaired breathing during sleep due to upper airway obstruction, affects millions of people, especially those who are overweight. Clinical studies have shown that by promoting significant weight loss, Zepbound helps relieve the symptoms of sleep apnea.
In two 52-week studies, participants with obesity and moderate to severe OSA experienced a "statistically significant and clinically meaningful reduction" in breathing interruptions during sleep compared to those taking placebo. These results were consistent in patients using CPAP machines and those not using them.
"This is a big step forward for patients with obstructive sleep apnea," says Dr. Sally Seymour, director of the FDA's Division of Pulmonology, Allergy and Critical Care Medicine.
The American Academy of Sleep Medicine (AASM) welcomed the approval, but stressed that weight loss alone is not a one-size-fits-all solution for sleep apnea, as factors such as jaw and airway structure also play a role. The AASM also noted that sustained weight loss is essential to the effectiveness of the medication.
Zepbound, known by the generic name tirzepathide, was first approved in November 2023 for the treatment of obesity and is part of the GLP-1 agonist drug class. Researchers are now exploring its potential to address other health conditions, such as addiction and some cancers. | BGNES