First Drug to Treat Obstructive Sleep Apnea Approved by FDA

The Food and Drug Administration (FDA) has approved Zepbound (tirzepatide; Eli Lilly and Company, Indianapolis, IN) for the treatment of moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity. Zepbound is a dual-activating glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic (GIP) medication originally approved by the FDA in 2022 for the treatment of adults with type 2 diabetes mellitus, with an additional approval in 2023 for chronic weight management. Treatment is administered by subcutaneous injection once weekly and is indicated for use in conjunction with a reduced-calorie diet and increased physical activity.

The approval is based on positive data from the phase 3, multi-center, randomized, double-blind, parallel, placebo-master protocol SURMOUNT-OSA clinical trial (NCT0512004), which included 469 participants with moderate-to-severe OSA and obesity. Participants were randomized 1:1 to receive either Zepbound 10 mg, Zepbound 15 mg, or placebo with or without positive airway pressure (PAP). The primary endpoint was a superior change in apnea-hypopnea index (AHI) from baseline compared with placebo at 52 weeks.

• For participants not receiving PAP therapy, Zepbound treatment was shown to be 5-times more effective than placebo in reducing breathing disruptions.
• People on PAP therapy who received Zepbound treatment experienced 29 fewer breathing disruptions from baseline compared with those receiving placebo.
• After 1 year, 42% of participants treated with Zepbound experienced remission from OSA compared with 16% of those receiving placebo.
• After 1 year, 50% of participants treated with Zepbound had mild, nonsymptomatic OSA compared with 14% of those receiving placebo.
• Participants treated with Zepbound lost an average of 18% of their bodyweight, and those also receiving PAP therapy lost an average 20% of their body weight.

"Zepbound is the first medication that significantly improves moderate-to-severe OSA and aids in long-term weight loss in adults with obesity,” said Patrik Jonsson, Executive Vice President and President of Lilly USA and Lilly Cardiometabolic Health. “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."