Prothena Corporation plc（纳斯达克代码：PRTA）今日宣布，其合作伙伴诺和诺德公司已成功获得美国食品药品监督管理局（FDA）授予的快速通道资格认定，该认定针对其在研药物Coramitug（研发代码：Prx004）用于治疗伴有心肌病的转甲状腺素蛋白淀粉样变性（ATTR-CM）。
此项重要的监管里程碑将有望加速Coramitug的临床开发与审评进程，为罹患此种严重疾病的患者带来新的治疗希望。快速通道资格旨在促进针对严重疾病且能够满足未竟医疗需求的药物的开发和审评。
ATTR-CM是一种进行性、可能危及生命的疾病，由错误折叠的转甲状腺素蛋白在心肌中沉积形成淀粉样纤维所致。Coramitug作为一种在研的单克隆抗体，其设计目标是选择性清除这些致病蛋白沉积。
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