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Tafamidis符合甲状腺素心肌病III期试验的主要目标

2018-04-03 MedSci MedSci原创

Tafamidis甲状腺素心肌病安慰剂
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辉瑞近日宣布，Tafamidis的III期临床试验（ATTR-ACT）结果显示，与安慰剂相比，Tafamidis可显著降低甲状腺素心肌病患者的全因死亡率和心血管相关住院率。

辉瑞近日宣布，Tafamidis的III期临床试验（ATTR-ACT）结果显示，与安慰剂相比，Tafamidis可显著降低甲状腺素心肌病患者的全因死亡率和心血管相关住院率。

Tafamidis于2011年首次在欧洲获得批准，商品名为Vyndaqel，用于治疗成年人中的甲状腺素蛋白家族性淀粉样多发性神经病变（TTR-FAP）。辉瑞公司于2010年通过收购FoldRx制药公司获得了该药物，并于2012年收到FDA关于批准Tafamidis用于TTR-FAP申请的完整回复函。尽管该疗法在美国尚未得到批准，但该疗法已经被美国食品和药物管理局于2017年6月授予了快速通道资格用于甲状腺素蛋白心肌病的治疗。与此同时，辉瑞表示，Tafamidis也将由日本监管机构根据未经批准药物的快速授权计划对甲状腺素蛋白心肌病进行审查。

ATTR-ACT试验包括441名患有遗传性或野生型甲状腺素蛋白心肌病的患者。患者随机接受口服每日剂量的Tafamidis及安慰剂。主要临床结果是30个月内全因死亡率和心血管相关住院频率。

原始出处：

http://www.firstwordpharma.com/node/1553116#axzz5BZmS3b4V

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    2018-05-12 juliusluan78

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    2018-05-12 爆笑小医

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