[US Food and Drug Administration Approves First Prescription Medicine for Obstructive Sleep Apnea
The US Food and Drug Administration (FDA) has approved the use of the weight-loss drug Zepbound as a treatment for moderate to severe forms of obstructive sleep apnea (OSA) in patients with obesity. The approval comes after two company-sponsored clinical trials showed that the medicine, part of the class known as GLP-1 receptor agonists, can help reduce the number of breathing disruptions during sleep and weight loss.
The FDA’s Division of Pulmonology, Allergy, and Critical Care director, Dr. Sally Seymour, called the approval “a major step forward for patients with obstructive sleep apnea.” The condition, which affects as many as 30 million people in the US, is closely linked to obesity, and weight loss can help reduce its severity.
The drug, developed by Eli Lilly, was initially approved for weight loss in November 2023. The new approval for sleep apnea treatment is based on the same clinical trials that demonstrated the medicine’s weight loss benefits.
The FDA approval does not expand the number of people eligible for the drug, as it is only approved for patients with obesity. However, it could lead to insurance coverage for patients with sleep apnea on Medicare, which currently only covers medications for weight loss when used to reduce the risk of heart problems.
Zepbound’s approval is based on two clinical trials of about 470 patients. The main goal of the trials was to improve the apnea-hypopnea index, a measure of breathing disruptions during sleep. In both studies, patients who took Zepbound showed significant improvements in this metric, as well as significant weight loss, with participants losing an average of 45-50 pounds over a year.
The most common side effects of Zepbound were gastrointestinal events, which were typically mild to moderate and happened most during the initial period of treatment.
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