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杨森向欧盟提交旗下白血病药物Ibrutinib的上市许可申请

2013-11-04 fyc5078 丁香园

白血病药物ibrutinib
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杨森向欧盟药品监管机构提交了旗下用于治疗两种形式血癌的药物Ibrutinib的上市许可申请。欧洲药品管理局(EMA)现在将决定杨森提供的数据是否支持这款药物用于治疗复发性或难治性慢性淋巴细胞性白血病(CLL)/ 小淋巴细胞性白血病(SLL)及套细胞淋巴瘤(MCL)。Ibrutinib是杨森母公司强生研发组合中处于研发最晚期的药物之一，并且今年早些时间这款药物被评为公司到2017年之前预计提交申请的



杨森向欧盟药品监管机构提交了旗下用于治疗两种形式血癌的药物Ibrutinib的上市许可申请。欧洲药品管理局(EMA)现在将决定杨森提供的数据是否支持这款药物用于治疗复发性或难治性慢性淋巴细胞性白血病(CLL)/ 小淋巴细胞性白血病(SLL)及套细胞淋巴瘤(MCL)。

Ibrutinib是杨森母公司强生研发组合中处于研发最晚期的药物之一，并且今年早些时间这款药物被评为公司到2017年之前预计提交申请的10款药物之一。这款日服一次的口服药物是一种叫做布鲁顿酪氨酸激酶(BTK)抑制剂的新类型癌症药物中的首款药物，这类药物通过与癌变细胞B细胞中的BTK蛋白质结合，使细胞增殖停止而起作用。

后期试验数据支持这款药物增加数月总生存期的能力，分析师预测Ibrutinib所有可能癌症适应症的年销售峰值会达到5亿美元。美国食品药品管理局(FDA)曾授予Ibrutinib突破性治疗药物资格，意味着这款药物的审评将被加快，在审评过程中杨森将提供更多的FDA指南。

杨森在获得FDA突破性治疗资格后于今年7月份向FDA提交了这款药物的上市申请。杨森EMEA主席Jane Griffiths将Ibrutinib的EMA申报资料提交描述为一个“重要里程碑”。她说：“如果获得批准，对于CLL/SLL及之前治疗失败或对之前治疗产生耐药的患者来说， Ibrutinib将提供一个极好的选择。”

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    2013-12-12 12498b08m90暂无昵称

    #白血病药#

    0

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    2014-08-07 珙桐

    #白血病药物#

    0

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    2014-09-27 xinxin088

    #上市许可#

    0

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    2013-11-06 陆成振

    #杨森#

    0

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    2013-11-06 xsm924

    #ibrutinib#

    0