艾伯维帕金森新药再次收到FDA发出的CRL

医药魔方06-26

6月25日，艾伯维宣布，收到了FDA就ABBV-951（foslevodopa / foscarbidopa）用于晚期帕金森病运动症状波动（motor fluctuations）的新药上市申请（NDA）发出的完整回复函（CRL）。艾伯维表示，FDA列出了在对第三方合同生产组织检查中观察到的结果，但这次检查并不涉及ABBV-951及设备。此外，CRL也没有确定ABBV-951（包括器械）安全性、...

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fluctuations）的新药上市申请（NDA）发出的完整回复函（CRL）。艾伯维表示，FDA列出了在对第三方合同生产组织检查中观察到的结果，但这次检查并不涉及ABBV-951及设备。此外，CRL也没有确定ABBV-951（包括器械）安全性、有效性、标签相关的任何问题，且没有要求其补充额外的疗效和安全性试验。言下之意，FDA本次CRL并未发现与ABBV-951相关的问题，仅仅与第三方生产商有关。不过，这并非FDA首次拒绝批准ABBV-951上市。此前在2023年3月，ABBV-951已经收到过FDA发出的CRL，当时FDA是对ABBV-951设备（泵）提出了要求，需要艾伯维提供额外信息支持NDA。ABBV-951是左旋多巴和卡比多巴的前体药物，具有较高水溶性，可以通过一个连接到皮下的泵实现持续24小时皮下输注给药，从而使体内的左旋多巴和卡比多巴浓度在24h内保持稳定，改善晚期帕金森病患者的药效波动。帕金森病是一种年龄相关的神经退行性疾病，特征是黑质多巴胺能神经元逐渐缺失，导致运动迟缓、肌肉强直、静止性震颤等运动症状。左旋多巴是治疗帕金森病使用最广泛和最有效的药物。不过帕金森病患者在长期使用左旋多巴类药物后会出现药效波动的副作用，患者症状在突然缓解和加重之间波动，而且与服药的时间、血药浓度无关，不可预知，因此在临床上也被称为“开-关现象”(on-off)。此前一项III期头对头M15-736 Study研究的结果显示，皮下注射ABBV-951相比口服速效左旋多巴/卡比多巴（LD/CD）能够显著延长晚期帕金森病患者无运动障碍的缓解时间（“on” time）。在治疗第12周，ABBV-951治疗组“on”时间增加2.72小时，而口服LD/CD治疗组增加0.97小时（p=0.0083）。ABBV-951治疗组早在第1周就观察到“on”时间的改善，并持续至第12周。此外，在第1周时，与口服LD/CD组相比，治疗组“off”的时间较基线也出现类似的改善，并持续12周。治疗12周时，ABBV-951组“off”时间降低了2.75小时，而口服药物组降低了0.96小时。ABBV-951组的大多数不良事件不严重或仅为轻中度。口服LD/CD组报告1例治疗相关不良事件导致的死亡，而ABBV-951组没有发生死亡。ABBV-951组最常见（≥5%）不良事件包括输液部位不良事件（红斑、疼痛、蜂窝织炎、水肿、瘀伤、出血、结节、硬结、感染和瘙痒）、运动障碍、“ON”和“OFF”现象、跌倒、幻觉（包括视觉幻觉）、平衡紊乱、便秘、外周肿胀。Copyright © 2024 PHARMCUBE. 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