FDA approves GLP-1 for OSA 

WASHINGTON – The U.S. Food and Drug Administration announced Dec. 20 that it has approved Zepbound (tirzepatide) for the treatment of moderate to severe sleep apnea in adults with obesity to be used in combination with a reduced-calorie diet and increased physical activity. 

“Today’s approval marks the first drug treatment option for certain patients with obstructive sleep apnea,” said Sally Seymour, M.D., director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research. “This is a major step forward for patients with obstructive sleep apnea.” 

Zepbound works by activating receptors of hormones secreted from the intestine (glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)) to reduce appetite and food intake. By reducing body weight, studies show that Zepbound also improves OSA, according to the FDA. 

Zepbound’s approval for moderate to severe OSA in adults with obesity is based on two randomized, double-blind, placebo-controlled studies of 469 adults without Type 2 diabetes. One study enrolled participants using positive airway pressure (PAP), the standard of care for moderate to severe OSA, and one study enrolled participants unable or unwilling to use PAP. In both studies, participants randomly received either 10 or 15 milligrams of Zepbound or placebo once weekly for 52 weeks. 

The results: After 52 weeks of treatment in both studies, participants who received Zepbound experienced a statistically significant and clinically meaningful reduction in events of apnea or hypopnea as measured by AHI compared with placebo, and greater proportions of participants treated with Zepbound achieved remission or mild OSA with resolution of symptoms compared to placebo. Participants treated with Zepbound had a significant decrease in body weight compared with placebo at 52 weeks. The improvement in AHI in participants with OSA is likely related to body weight reduction with Zepbound.    

Zepbound received Fast Track, Priority Review and Breakthrough Therapy designations for this indication. 

The FDA granted approval to Eli Lilly and Co.