FDA

FDA approves first medication for sleep apnea

December 24, 2024

Brand name: Zepbound

Generic name: tirzepatide

Manufacturer: Eli Lilly

Approval date: December 20, 2024

FDA approved Zepbound (tirzepatide), a dual GIP and GLP-1 receptor agonist, for the treatment of moderate to severe obstructive sleep apnea (OSA) in adults with obesity, to be used in combination with a reduced-calorie diet and increased physical activity.

Efficacy

Approval for the new indication was based on data from the randomized, double-blind, placebo-controlled SURMOUNT-OSA (NCT05412004) studies involving 469 adults without type 2 diabetes. One study enrolled participants using positive airway pressure (PAP), and one study enrolled participants unable or unwilling to use PAP. In both studies, participants randomly received either 10 or 15 mg of tirzepatide or placebo once weekly for 52 weeks. The primary measure of efficacy was the change from baseline in the apnea hypopnea index (AHI) at week 52. After 52 weeks of treatment in both studies, tirzepatide recipients experienced a statistically significant and clinically meaningful reduction in apnea or hypopnea events as measured by AHI compared with placebo, and greater proportions of participants treated with tirzepatide achieved remission or mild OSA with resolution of symptoms compared with placebo. Tirzepatide also led to 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.

Safety

Adverse effect associated with tirzzepatide include nausea, diarrhea, vomiting, constipation, abdominal discomfort and pain, injection site reactions, fatigue, hypersensitivity reactions, burping, hair loss, and GERD.

Tirzepatide can cause thyroid C-cell tumors in rats. It’s unknown whether it causes such tumors, including medullary thyroid cancer, in humans. Tirzepatide shouldn’t be used in patients with a personal or family history of medullary thyroid cancer or in patients with multiple endocrine neoplasia (MEN) syndrome type 2.

Recommended dose

The recommended dosage of Zepbound for OSA is 10 or 15 mg SC once weekly.

Sources:

FDA. (2024, December 20). FDA Approves First Medication for Sleep Apnea. [Press release]. https://www.fda.gov/news-events/press-announcements/fda-approves-first-medication-obstructive-sleep-apnea

Eli Lilly. (2024, December 20). FDA approves Zepbound (tirzepatide) as the first and only prescription medicine for moderate-to-severe obstructive sleep apnea in adults with obesity. [Press release]. https://investor.lilly.com/news-releases/news-release-details/fda-approves-zepboundr-tirzepatide-first-and-only-prescription