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安斯泰来他克莫司缓释胶囊（ASTAGRAF XL）获FDA批准

2013-07-22 tomato 生物谷

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安斯泰来（Astellas）美国子公司今天宣布，ASTAGRAF XL（他克莫司缓释胶囊，tacrolimus extended release capsules）获FDA批准，与霉酚酸酯（MMF）及皮质类醇联用、结合或无巴利昔单抗（basiliximab）诱导，用于预防成人肾移植受者中的器官排斥。安斯泰来于2012年9月提交了该药的新药申请（NDA）。 在美国，ASTAGRAF XL是首个

安斯泰来（Astellas）美国子公司今天宣布，ASTAGRAF XL（他克莫司缓释胶囊，tacrolimus extended release capsules）获FDA批准，与霉酚酸酯（MMF）及皮质类醇联用、结合或无巴利昔单抗（basiliximab）诱导，用于预防成人肾移植受者中的器官排斥。安斯泰来于2012年9月提交了该药的新药申请（NDA）。

在美国，ASTAGRAF XL是首个每日一次的他克莫司制剂，该药作为免疫抑制组合方案中的核心组成部分，为肾移植受者预防器官排斥反应提供了一个很有潜力的疗法。

该药的获批，是基于2项主要的、随机、比较III期临床研究，涉及美国、欧洲、加拿大、南美、澳大利亚、南非等国的1093例患者（545例他克莫司缓释胶囊治疗）。

在2007年，他克莫司缓释胶囊在欧洲获批以商品名Advagraf销售；2008年，该药在日本获批以商品名Graceptor销售。总体而言，他克莫司缓释胶囊已获得了全球73个国家的监管批准，每年经该药治疗的患者数超过14万人。

原文链接：Astellas Announces FDA Approval of ASTAGRAF

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    2013-09-15 aliceclz

    #安斯泰来#

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    2013-12-11 by2009

    #缓释胶囊#

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    2013-10-18 ms24272190615788285182

    #AST#

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    2013-08-12 bugit

    #FDA批准#

    0

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    2013-07-24 12498b08m90暂无昵称

    #他克莫司#

    0

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