Eli Lilly expects FDA decision on weight loss drug Zepbound for sleep apnea as early as end of the year

Core Viewpoint - Eli Lilly has applied for U.S. approval of its weight loss drug Zepbound for treating obstructive sleep apnea (OSA) and anticipates a regulatory decision by the end of the year, with plans to launch in early 2025 if approved [1][2] Group 1: Drug Efficacy and Trials - Zepbound demonstrated effectiveness in resolving OSA in nearly half of the patients in late-stage trials, with 43% in the first study and 51.5% in the second study achieving "disease resolution" [4][5] - The drug led to an average reduction of 27.4 AHI events per hour in patients not on PAP machines and 30.4 events in those on PAP machines after 52 weeks [6] - 62.3% of patients in the first trial and 74.3% in the second trial experienced more than a 50% reduction in AHI events compared to 19.2% and 22.9% in placebo groups, respectively [5][6] Group 2: Market Potential and Insurance Coverage - The growing evidence of health benefits from weight loss and diabetes treatments like Zepbound may lead to broader insurance coverage, which is currently limited for such drugs [2] - Approximately 80 million people in the U.S. suffer from OSA, with 20 million having moderate-to-severe forms, indicating a significant market opportunity for Zepbound [3] Group 3: Regulatory Status - Zepbound has received "fast track designation" from the FDA for patients with moderate-to-severe OSA and obesity, facilitating quicker review due to its potential to address an unmet medical need [6]