US-based pharmaceutical company Eli Lilly and Co announced on Friday that it has received approval from the US Food and Drug Administration for its Zepbound (tirzepatide) intended for the treatment of moderate to severe obstructive sleep apnoea (OSA) in adults with obesity.

Zepbound is to be used in conjunction with a reduced-calorie diet and increased physical activity. Its approval for moderate to severe OSA in adults with obesity is based on two randomised, double-blind, placebo-controlled studies of 469 adults without type 2 diabetes. One study enrolled subjects using positive airway pressure (PAP), the standard of care for moderate to severe OSA and one study enrolled subjects unable or unwilling to use PAP. During both studies, subjects randomly received either 10 or 15 milligrams of Zepbound or placebo once weekly for 52 weeks.

The study's primary measure of efficacy was the change from baseline in the apnoea hypopnea index (AHI), a measurement of how many times a person stops breathing (apnoea) or breathes shallowly (hypopnea) per hour during sleep, at week 52. Subsequent to 52 weeks of treatment in both studies, subjects who received the product experienced a significant and clinically meaningful decrease in events of apnoea or hypopnea as measured by AHI compared with placebo, and greater proportions of subjects treated with Zepbound achieved remission or mild OSA compared to placebo. Subjects treated with the product had a significant decrease in body weight compared with placebo at 52 weeks.

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