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强生旗下TB药物Sirturo获欧盟支持 梯瓦制药旗下MS药物Laquinimod被推迟

2013-12-25 佚名 dxy

SirturoLaquinimod
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12月20日，欧洲药品监管机构推荐批准强生旗下一款创新性肺结核药物，但梯瓦制药备受期待的多发性硬化症新药的推荐批准决定确被推迟。欧洲药品管理局(EMA)称强生旗下的Sirturo作为一款多重抗药性结核病治疗药物已获得支持，这该药物于去年12月份获得美国上市批准。 此前预计EMA将在本周对梯瓦制药的Laquinimod做出是否推荐批准的决定，但这次的决定被推迟了，这款药物用于治疗多发性硬化症，

12月20日，欧洲药品监管机构推荐批准强生旗下一款创新性肺结核药物，但梯瓦制药备受期待的多发性硬化症新药的推荐批准决定确被推迟。欧洲药品管理局(EMA)称强生旗下的Sirturo作为一款多重抗药性结核病治疗药物已获得支持，这该药物于去年12月份获得美国上市批准。

此前预计EMA将在本周对梯瓦制药的Laquinimod做出是否推荐批准的决定，但这次的决定被推迟了，这款药物用于治疗多发性硬化症，由梯瓦制药与其瑞典合作伙伴Active生物技术公司联合开发。Active生物技术表示它期望EMA能在明年1月份做出是否推荐批准的决定。EMA一位发言人对这款产品拒绝给出更一步的细节，但称EMA专家如果认为有必要，可能会推迟做出决定。

分析师们认为Laquinimod的前景不明朗，因为这款药物在2011年的后期临床试验中没能达到其主要终点，并且FDA指出在考虑批准这款药物之前，要求提供另一项III期临床研究资料。尽管受到挫折，但梯瓦制药仍希望2014年能在欧洲上市这款药物。如果能在2014年上市，那该药物将进入一个越来越拥挤的市场，来自诺华、百健艾迪和赛诺菲的口服多发性硬化症治疗药物已获得批准。EMA人用医药产品委员会(CHMP)的药品上市推荐意见通常会在几个月内得到欧盟的支持。

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    2014-04-29 zxl729

    #MS药物#

    0

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    2014-06-06 ms55066533437992

    #梯瓦制药#

    0

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    2013-12-27 liuyong2980

    #强生#

    0