药物适应症获批

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礼来:替尔泊肽注射液第三项适应症获批,改善阻塞性睡眠呼吸暂停肥胖成人患者的睡眠障碍
Cai Jing Wang· 2025-07-03 09:18
Core Insights - Eli Lilly's drug Mounjaro (tirzepatide) has received approval from China's National Medical Products Administration (NMPA) for a new indication to treat moderate to severe obstructive sleep apnea (OSA) in obese adults, marking it as the first and only prescription medication for this condition in China [1] - The approval is based on the results of the SURMOUNT-OSA Phase 3 clinical trial, which evaluated the drug's effectiveness in obese adults with OSA who were either receiving or unwilling to receive positive airway pressure (PAP) therapy [1] Group 1: Clinical Trial Results - Tirzepatide reduced the number of apnea-hypopnea events by five times compared to placebo in adults not using PAP, with a reduction of 27 events per hour versus 5 for placebo [2] - In adults using PAP, tirzepatide led to a reduction of 30 events per hour compared to 6 for placebo [2] - After one year of treatment, 43% of patients using tirzepatide alone achieved complete resolution of OSA symptoms or a mild OSA state, while 52% of those using both tirzepatide and PAP achieved similar results; the placebo group had rates of 15% and 14% respectively [2] Group 2: Weight Loss and Safety - Patients treated with tirzepatide alone experienced an average weight loss of 18.1%, while those receiving both tirzepatide and PAP lost an average of 20.1%; the placebo group saw weight losses of 1.3% and 2.3% respectively [2] - The safety and tolerability profile of tirzepatide remained consistent with previous trials, with gastrointestinal adverse events being the most common, typically mild to moderate in severity [2]