FDA Approves Tirzepatide for Obstructive Sleep Apnea in Patients with Obesity
Zepbound from Eli Lilly is the first and only prescription medicine approved by the FDA for adults with obstructive sleep apnea and obesity.
The FDA approved tirzepatide (Zepbound) for the treatment of moderate-to-severe obstructive sleep apnea and obesity, Eli Lilly announced in a release.1 The therapy, which is the first and only prescription medicine for adults with both conditions, is indicated to be used with a reduced-calorie diet and increased physical activity.
FDA Approves Tirzepatide for Obstructive Sleep Apnea in Patients with Obesity / Tada Images - stock.adobe.com
The approval of tirzepatide for obstructive sleep apnea and obesity was based on data from the SURMOUNT-OSA trial (NCT05412004), in which the therapy met its primary endpoint of change from baseline in the Apnea-Hypopnea Index. Tirzepatide also met all key secondary endpoints, including percent change from baseline in the Apnea-Hypopnea Index, percentage of patients with 50% or more reduction in the Apnea-Hypopnea Index, and change from baseline in sleep apnea-specific hypoxic burden.
Results from the SURMOUNT-OSA trial were published in the New England Journal of Medicine.2
“Today’s approval marks the first drug treatment option for certain patients with obstructive sleep apnea,” Sally Seymour, MD, director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research, said in a release.3 “This is a major step forward for patients with obstructive sleep apnea.”
SURMOUNT-OSA was a multi-center, randomized, double-blind, parallel, phase 3 placebo-master protocol that included 2 studies in adults living with moderate-to-severe obstructive sleep apnea and obesity. In the first study, tirzepatide’s efficacy and safety was evaluated in patients who were unable or unwilling to use positive airway pressure therapy (PAP), while the second study evaluated the therapy in patients who were and planned to stay on PAP therapy during the study period.
The study cohorts included a total of 469 patients who randomly received either a maximum tolerated dose of 10 mg or 15 mg tirzepatide or placebo. Patients were initially given a starting dose of 2.5 mg tirzepatide, which was increased by 2.5 mg every 4 weeks until the maximum tolerated dose was achieved. The studies took place at centers across the US, Australia, Brazil, China, Czechia, Germany, Japan, Mexico and Taiwan.
At baseline, the mean Apnea-Hypopnea Index was 51.5 events per hour in the first study and 49.5 events per hour in the second study. In the first study, the mean change in Apnea-Hypopnea Index at week 52 was −25.3 events per hour with tirzepatide and −5.3 events per hour for placebo. In the second study, the mean change in Apnea-Hypopnea Index at week 52 was −29.3 events per hour with tirzepatide and −5.5 events per hour for placebo. Of patients who received tirzepatide at the highest dose, 43% in the first study and 51.5% in the second study met the criteria for disease resolution.
Additionally, patients on Pap therapy who received tirzepatide lost an average of 20% of their body weight, while patients not on PAP therapy lost an average of 18% of their body weight.
"Too often, obstructive sleep apnea is brushed off as 'just snoring'—but it's far more than that," Julie Flygare, JD, president and CEO of Project Sleep, said in a release.1 "It's important to understand obstructive sleep apnea symptoms and know that treatments are available, including new options like Zepbound. We hope this will spark more meaningful conversations between patients and health care providers and ultimately lead to better health outcomes.”
READ MORE: FDA Updates Resource Center
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