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| An Eli Lilly & Co. Zepbound injection pen arranged in the Brooklyn borough of New York, US, on Thursday, March 28, 2024. |
In a groundbreaking development, the U.S. Food and Drug Administration (FDA) has approved Zepbound® (tirzepatide), the first-ever prescription medication for treating moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity. The approval provides a new option for the millions of individuals who suffer from this life-altering condition, marking a significant milestone in sleep disorder management.
“Today’s approval marks the first drug treatment option for certain patients with obstructive sleep apnea,” said Dr. Sally Seymour, Director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research.
Obstructive sleep apnea is a common but often undiagnosed sleep disorder characterized by repeated blockages of the upper airway during sleep, leading to pauses in breathing. While the condition is frequently associated with snoring, its effects are far more severe, including excessive daytime sleepiness, fatigue, and an increased risk of cardiovascular diseases.
Until now, treatment options such as continuous positive airway pressure (PAP) devices or surgical interventions have been the mainstay for managing OSA. However, PAP therapy, while effective, has limitations due to poor adherence among some patients.
Zepbound’s approval is based on promising results from the SURMOUNT-OSA Phase 3 clinical trials. The trials evaluated the efficacy and safety of the medication over 52 weeks in 469 participants, both with and without PAP therapy. The medication demonstrated remarkable results, reducing the frequency of breathing disruptions by up to 25 events per hour in patients not using PAP and 29 events per hour in those on PAP therapy. Notably, up to 50% of patients on Zepbound achieved remission or mild OSA symptoms.
Zepbound also targets obesity, a major contributor to OSA. By activating receptors that regulate appetite and food intake, participants experienced an average weight loss of 45-50 pounds over the year-long trial. This weight reduction correlated strongly with improvements in OSA symptoms.
Despite its benefits, Zepbound carries significant risks. Common side effects include nausea, diarrhea, abdominal discomfort, and fatigue. Serious warnings include the potential for thyroid tumors, pancreatitis, gallbladder issues, and low blood sugar. Patients with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2 should avoid the medication. Additionally, careful monitoring is advised for individuals with kidney disease or depression.
Experts in the field emphasize the significance of this approval. “Too often, OSA is brushed off as 'just snoring'- but it’s far more than that,” said Julie Flygare, President of Project Sleep. “This approval opens doors for meaningful conversations between patients and healthcare providers, leading to better health outcomes.''
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| The FDA first approved Zepbound to treat obesity in November 2023. Image by Washington Post |
With nearly 30 million adults in the U.S. estimated to suffer from OSA, Zepbound’s approval has the potential to revolutionize treatment paradigms. Beyond alleviating OSA symptoms, it may reduce the associated risks of heart disease, hypertension, and other obesity-related conditions, providing comprehensive health benefits.
The FDA granted Zepbound Fast Track, Priority Review, and Breakthrough Therapy designations, underscoring the urgency and importance of addressing this unmet medical need. Eli Lilly, the manufacturer of Zepbound, has expressed its commitment to furthering research and accessibility for this innovative therapy.
As the first medication of its kind, Zepbound represents a pivotal moment for the millions grappling with OSA and its debilitating effects. The integration of medical and lifestyle interventions offers hope for improved quality of life and better long-term outcomes.