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拜耳公司抗凝血药物Xarelto获英国NICE推荐

2012-04-16 potato 生物谷

2012年3月30日,英国国家卫生与临床优化研究所(National Institute for Health and Clinical Excellence,NICE)在指导草案中推荐拜耳(Bayer)公司口服抗凝血剂拜瑞妥(Xarelto)用于房颤患者(atrial fibrillation ,AF),预防中风及全身性的栓塞。最终的指导意见将在4月份出台。 NICE最初否决了该药,要求拜耳公

2012年3月30日,英国国家卫生与临床优化研究所(National Institute for Health and Clinical Excellence,NICE)在指导草案中推荐拜耳(Bayer)公司口服抗凝血剂拜瑞妥(Xarelto)用于房颤患者(atrial fibrillation ,AF),预防中风及全身性的栓塞。最终的指导意见将在4月份出台。

NICE最初否决了该药,要求拜耳公司提供额外的临床证据及成本效益(cost-effectiveness)信息。NICE卫生技术评估中心主任Carole Longson教授称,拜耳此次所提交的新数据正是他们所需要的,基于这些信息,NICE对Xarelto进行了推荐。

NICE已批准了勃林格殷格翰(Boehringer Ingelheim)公司在该领域的首个上市药物Pradaxa。一些具有类似疗效的药物正在纷纷抢占市场份额。Pradaxa和Xarelto已被FDA批准用于心脏节律异常(如房颤)患者预防中风,Xarelto也已被批准用于特定手术患者,以减少凝血的风险。

预计辉瑞(Pfizer)和百时美施贵宝(Bristol-Myers Squibb)公司也将通过其产品Eliquis挤进市场,在所有竞争药物中,该药具有一些最强劲的数据。但FDA最近将该药的审批推迟了3个月,以审查一些额外的信息。

Pradaxa上市的时间比Xarelto早几个月,到目前为止,勃林格殷格翰公司在市场中占据着最大的份额。但最近有报道称,一些服用Pradaxa的患者出现了严重的出血情况,这使得欧盟监管机构和勃林格殷格翰公司建议,在某些患者中需慎用该药。(生物谷bioon.com)

编译自:FiercePharma
http://www.fiercepharma.com/story/bayer-gets-positive-ruling-nice-xarelto/2012-03-30

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    2012-04-18 fusion
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    2012-04-18 ying_wu
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