FDA接受百时美施贵宝及辉瑞Eliquis补充新药申请（sNDA）

2013年7月15日讯 /生物谷BIOON/ --百时美施贵宝（BMS）和辉瑞（Pfizer）7月11日宣布，FDA已接受有关Eliquis的补充新药申请（sNDA）。目前，这2家公司正寻求FDA批准Eliquis用于已开展髋关节或膝关节置换术的成人患者，预防深层静脉血栓（DVT）的形成。DVT可能会导致致死性的肺栓塞（PE）。FDA预计将在2014年3月15日作出最终审查决定。

Eliquis sNDA的提交，是基于ADVANCE-1、 ADVANCE-2、 ADVANCE-3临床研究以及EXPANSE项目的一部分数据，这些研究中，将Eliquis与赛诺菲（Sanofi）的依诺肝素（Lovenox，enoxaparin）进行了安全性和疗效比较。

Eliquis是一种Xa因子抑制剂，是唯一一种在中风及全身性栓塞、严重出血、全因死亡率等3个重要预后中与华法林相比表现出卓越风险降低的口服抗凝血剂。

目前，该药已获欧盟及美国在内多个国家批准，用于降低非瓣膜性房颤患者卒中和全身性栓塞风险。此外，该药还获欧盟及一些国家批准，用于已接受择期髋关节或膝关节置换手术成人患者预防静脉血栓栓塞事件（VTE）。（生物谷Bioon.com）

英文原文：BMY/Pfizer Seek to Expand Eliquis Label

Bristol-Myers Squibb Company (BMY) and partner Pfizer Inc. (PFE) recently announced that their supplemental New Drug Application (sNDA) for Eliquis has been accepted by the US Food and Drug Administration (:FDA). The companies are looking to get the drug approved for the prevention of deep vein thrombosis (:DVT) in adults who have undergone hip or knee replacement surgery.

We note that DVT can lead to pulmonary embolism (:PE), which can be fatal. The FDA is expected to render a final decision on the drug by Mar 15, 2014.

The sNDA was submitted on the basis of data from ADVANCE-1 and ADVANCE-2 (evaluating the use of Eliquis in patients undergoing elective total knee replacement) and ADVANCE-3 (evaluating the use of Eliquis in patients undergoing elective hip replacement) along with a part of the EXPANSE program. These trials compared the safety and efficacy of Eliquis to Sanofi’s (SNY) Lovenox (enoxaparin).

We note that Eliquis, a Factor Xa inhibitor, was launched in multiple countries including the US and EU for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation in the first quarter of 2013. We believe that the label expansion of the drug will boost its sales potential.

Eliquis is also approved in the EU and some other nations for prevention of venous thromboembolic events (:VTE) events in adults, who have undergone elective hip or knee replacement surgery.

Other Factor Xa inhibitors currently available in the market include Xarelto, which is approved for several indications including prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery.

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