The U.S. Food and Drug Administration (FDA) has approved Zepbound, the first prescription medication for obstructive sleep apnea (OSA). The drug, part of the GLP-1 receptor agonist class that includes Ozempic, is designed to treat moderate to severe OSA in people with obesity. According to Eli Lilly, the manufacturer, Zepbound should be used alongside a reduced-calorie diet and increased physical activity.
“This approval marks a significant advancement for patients with obstructive sleep apnea,” said Dr. Sally Seymour, director of the FDA’s Division of Pulmonology, Allergy, and Critical Care, in the agency’s announcement.
OSA affects up to 30 million people in the U.S. and is closely linked to obesity, according to the American Academy of Sleep Medicine. Characterized by breathing disruptions during sleep due to blocked airflow, the condition increases the risk of cardiovascular and neurological issues. Weight loss is known to alleviate its severity.
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“Many cases of OSA remain undiagnosed and untreated, leaving millions vulnerable to severe health consequences,” said Patrik Jonsson, president of Lilly Cardiometabolic Health, in the company’s statement. He noted that clinical trials showed nearly half of participants experienced such significant improvement that they no longer exhibited OSA symptoms. Common symptoms of OSA include loud snoring, gasping during sleep, and excessive daytime drowsiness.
This approval marks the second indication for Zepbound, which was initially approved for weight loss in people with obesity or those overweight with weight-related health conditions in November 2023. While the new approval does not expand the eligible patient population, it may lead to insurance coverage for Medicare beneficiaries with OSA. Medicare currently excludes coverage for drugs intended solely for weight loss but may approve them for conditions like sleep apnea. The Biden administration has proposed changes to Medicare’s obesity drug coverage policy, but no changes have been enacted yet.
Without insurance, Zepbound costs $1,060 per month. However, Lilly offers discounts, coupons, and a lower-cost vial version for manual injection, potentially reducing out-of-pocket expenses to several hundred dollars monthly.
The FDA’s decision was based on two company-sponsored trials involving about 470 participants, including those treated with continuous positive airway pressure (CPAP) machines—a standard therapy to keep airways open. Results from these trials, published in the New England Journal of Medicine, showed significant benefits for patients using Zepbound.
The trials focused on the apnea-hypopnea index (AHI), which measures the frequency of breathing disruptions during sleep. At the start, participants had an average AHI of 50 events per hour and a body mass index (BMI) of approximately 39, indicating obesity (BMI ≥ 30).
In the trial without CPAP use, Zepbound users reduced their AHI by about 25 events per hour on average over one year, compared to a decrease of five events for those on placebo. In the CPAP trial, Zepbound users showed an average reduction of 29 events per hour, compared to six events for the placebo group.
Additionally, Zepbound led to significant weight loss. On average, participants lost 18% of their body weight in the first trial and 20% in the second, translating to 45–50 pounds over a year. In comparison, placebo users lost only 1.6% and 2.3% of their body weight. Patients also experienced reductions in blood pressure and inflammation, key risk factors for cardiovascular complications related to OSA and obesity.
The most common side effects of Zepbound were mild to moderate gastrointestinal issues, primarily occurring during the initial treatment phase or dosage increases.
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good job