6月27日消息 - 环球医学据悉，美国食品和药物管理局（FDA）已再次延迟对辉瑞和百时美施贵宝公司开发的一种实验性药物的批准，FDA表示它需要更多的关于该药物有效性的研究的信息。

一些分析师认为，此种名为Eliquis的药物要优于目前在市场上出售的两种新的血栓预防药物。然而，FDA表示，它需要更多的关于ARISTOTLE研究的数据管理和核查的数据，ARISTOTLE研究考察了Eliquis预防心房颤动（一种心律失常）患者发生卒中的有效性。

虽然分析师预测FDA至少需要一年才能再次决定是否批准该药，但施贵宝的发言人表示，希望审查过程能早些完成。她说，我们正与FDA合作，希望可以在较短的时间内完成对我们所提交申请的审查。（环球医学）

原文：

FDA Delays Approval of Clot-Busting Drug

The US Food and Drug Administration has once again delayed the approval of an experimental drug developed by Pfizer and Bristol-Myers Squibb, stating that it needs more information of the study which looked into the effectiveness of the drug. 

A number of analysts believe that the drug, known as Eliquis, is better than the two new clot-preventing drugs currently in the market. However the FDA said that it needs more data regarding data management and verification of the study known as ARISTOTLE which looked into the effectiveness of Eliquis preventing strokes in patients with an irregular heartbeat called atrial fibrillation. 

While analysts predict that it will take at least a year for FDA to once again decide on whether to approve the drug or not, a spokeswoman for Bristol-Myers Squibb expressed hope that the review process could be completed sooner. We are already working with the agency, and we are hopeful that the review of our submission can be completed within a shorter timeframe, she said. 
 

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