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FDA Approves Zepbound for Sleep Apnea Relief

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Eli Lilly’s (LLY) weight-loss drug Zepbound has received FDA approval as the first prescription medication to treat moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity. This landmark decision could make Zepbound eligible for Medicare coverage, placing it alongside Novo Nordisk’s (NVO) Wegovy in expanding access to obesity-related treatments.

The approval is based on clinical trial results demonstrating Zepbound’s effectiveness in significantly reducing breathing disruptions during sleep. In a study involving 469 participants with obesity and moderate-to-severe OSA, the drug reduced breathing interruptions by 27.4 events per hour (55%) in patients not using positive airway pressure (PAP) therapy and by 30.4 events per hour (62.8%) in those who continued PAP therapy.

Additionally, trial participants experienced substantial weight loss, averaging 18% and 20% of their body weight over 52 weeks. This dual benefit highlights Zepbound’s potential to address both sleep apnea and obesity.

“Nearly half of the participants achieved complete symptom relief, representing a significant step forward in reducing the burden of OSA and its related health challenges,” said Patrik Jonsson, President of Lilly Cardiometabolic Health and Lilly USA.

The FDA approval coincides with recent guidance from the U.S. Centers for Medicare and Medicaid Services (CMS) allowing FDA-approved anti-obesity drugs with additional medical indications to qualify as Part D medications. This policy opens the door for Zepbound to receive Medicare coverage, expanding its availability to millions of patients.

Zepbound’s approval reflects a growing emphasis on treating obesity-related conditions as part of comprehensive healthcare strategies. By targeting OSA, the drug addresses a condition that affects millions and is often linked to other serious health risks, such as heart disease and diabetes.

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As Zepbound enters the market, it represents a breakthrough in both sleep apnea and obesity management, offering new hope to those struggling with these interconnected conditions.

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