Eli Lilly has applied for U.S. approval of its weight loss drug Zepbound to treat obstructive sleep apnea (OSA), the most common sleep-related breathing disorder, with a decision expected by the end of the year. If the Food and Drug Administration (FDA) grants approval, Eli Lilly plans to launch Zepbound for OSA in early 2025. Patrik Jonsson, president of Eli Lilly diabetes and obesity, expressed optimism about the drug’s potential impact.
Eli Lilly released additional data from two late-stage trials, revealing that Zepbound resolved OSA in nearly half of the patients studied. The data, presented at the American Diabetes Association’s 84th Scientific Sessions, exceeded expectations of many external experts. This adds to the growing evidence that weight loss and diabetes treatments like Zepbound may offer broader health benefits.
The pharmaceutical company previously reported that Zepbound significantly reduced the severity of OSA in obese patients compared to a placebo after one year. OSA, characterized by interrupted breathing during sleep due to narrowed or blocked airways, affects an estimated 80 million people in the U.S., with around 20 million having moderate-to-severe forms. Alarmingly, 85% of OSA cases go undiagnosed, according to Jonsson.
OSA can lead to serious health complications, including stroke and heart failure, with limited treatment options available. Current treatments often involve cumbersome positive airway pressure (PAP) machines. Eli Lilly’s trials focused on adults with moderate-to-severe OSA and obesity, with one study excluding PAP therapy users and the other including them.
The new results indicated that 43% of participants in the first study and 51.5% in the second achieved “disease resolution” with the highest dose of Zepbound, compared to 14.9% and 13.6% of placebo users, respectively. Disease resolution is defined as having fewer than five apnea-hypopnea index (AHI) events per hour or a specific score on a survey measuring daytime sleepiness.
Additionally, 62.3% of patients in the first trial and 74.3% in the second experienced a more than 50% reduction in AHI events with Zepbound, significantly higher than the placebo groups. Zepbound led to an average of 27.4 fewer AHI events per hour in the first trial and 30.4 fewer events in the second trial after 52 weeks, compared to reductions of 4.8 and 6 events per hour for placebo users, respectively.
The FDA has granted Zepbound “fast track designation” for moderate-to-severe OSA and obesity, ensuring a quicker review process. This designation is given to drugs intended to treat serious conditions and fulfill unmet medical needs, highlighting Zepbound’s potential to provide significant relief to OSA patients.
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