The US Food and Drug Administration (FDA) has approved Zepbound, a weight-loss drug, as the first prescription medicine for treating obstructive sleep apnea (OSA). The approval is for moderate to severe forms of OSA in people with obesity. Zepbound should be used in conjunction with a reduced-calorie diet and increased physical activity.
Obstructive sleep apnea affects approximately 30 million people in the US, often associated with obesity. Weight loss can reduce its severity. Symptoms include snoring, gasping during sleep, and excessive daytime sleepiness.
According to Eli Lilly, Zepbound’s clinical trials showed significant improvements in patients taking the drug, with about half experiencing no symptoms of OSA. The FDA approval is based on two company-sponsored trials involving 470 participants, which demonstrated the effectiveness of Zepbound in reducing breathing disruptions and improving weight loss.
The trials showed that Zepbound reduced the apnea-hypopnea index (AHI) by an average of 25-29 events per hour, compared to a reduction of about five events per hour for those on placebo. Patients taking Zepbound also experienced significant weight loss, with an average of 18-20% weight loss over a year.
The approval could lead to insurance coverage for patients with OSA on Medicare, as the current policy only covers weight-loss medicines used for another indication. However, costs can be high out of pocket, with some reports citing prices ranging from hundreds to thousands of dollars per month.
Source: https://edition.cnn.com/2024/12/20/health/zepbound-sleep-apnea-fda-approval/index.html