FDA Approves Zepbound for Obstructive Sleep Apnea in Adults with Obesity
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The FDA recently approved the weight loss drug Zepbound (tirzepatide) for the treatment of moderate to severe obstructive sleep apnea (OSA) in adults with obesity. This approval marks a significant milestone as Zepbound becomes the first and only prescription drug specifically approved for this condition.
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Zepbound, developed by Eli Lilly, was initially approved for chronic weight management in adults with obesity. The drug has shown efficacy in reducing the number of breathing disruptions in OSA patients. In clinical trials, Zepbound was five times more effective than a placebo in reducing these disruptions, with participants experiencing an average reduction of 25 fewer disruptions per hour compared to five with the placebo.The approval was based on a 52-week clinical trial involving 469 participants with obesity and moderate to severe OSA. The trial demonstrated that Zepbound significantly reduced the average number of restricted or blocked breathing events by 27.4 events per hour (55%) for those not on positive airway pressure (PAP) therapy, and by 30.4 events per hour (62.8%) for those continuing on PAP therapy. Additionally, participants in both groups lost an average of 18% to 20% of their body weight from baseline.This new use for Zepbound could expand access to the medication, potentially allowing it to be covered by federal health insurance, including Medicare. The approval is expected to alleviate the burden of OSA and its associated health challenges, providing a new treatment option for patients with obesity-related sleep apnea.