FDA批准阿哌沙班用于预防髋关节或膝关节置换术后DVT

FDA批准阿哌沙班用于预防髋关节或膝关节置换术后DVT2014-03-17 09:22来源：丁香园作者：fyc5078字体大小：

                               
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辉瑞与百时美施贵宝于3月14日称，FDA批准两家公司的口服药物阿哌沙班一项新适应症，许可这款药物用于预防已进行膝关节或髋关节置换手术患者的深静脉血栓(DVT)。辉瑞公司全球创新药物部门药物开发组主管Steven Romano称，这款Xa因子抑制代表了“一种新的治疗选择，每天用药两次，不需要常规凝血检测，并且药品获取渠道广泛。”

这项批准决定基于阿哌沙班3期ADVANCE临床研究项目数据，这项有1.1万多名患者参与的临床研究将阿哌沙班的安全性及有效性与赛诺菲的依诺肝素进行了对比。

辉瑞与百时美施贵宝于去年12月时曾表示，FDA也接受了阿哌沙班另一项上市许可申请，即寻求批准阿哌沙班用于治疗DVT和肺栓塞(PE)，以及用于降低DVT和PE复发风险，预期FDA会在8月25日做出审批决定。阿哌沙班已在美国、欧洲、加拿大和日本获批用于降低非瓣膜房颤患者中风和全身性栓塞风险。

信源地址：http://www.firstwordpharma.com/node/1195709?tsid=28&region_id=6#axzz2vw0jyrkG

编辑： 诚意

2014年3月15日讯 /生物谷BIOON/ --百时美施贵宝（BMS）和辉瑞（Pfizer）3月14日宣布，抗凝剂Eliquis（apixaban,阿哌沙班）补充新药申请（sNDA）获FDA批准，用于接受髋关节或膝关节置换术的成人患者，预防深静脉血栓（DVT）的形成。

骨科大手术，如全髋关节或全膝关节置换术，是静脉血栓栓塞症（VTE）发生的重要危险因素之一。术后患者如不接受抗凝剂治疗，40-60%的患者会在术后7-14天内发生深静脉血栓(DVT)

深静脉血栓（DVT）是形成于大静脉中的血栓，通常在小腿、大腿或骨盆，当血栓的一部分或全部脱落并随着血液迁移到肺部，阻塞一个或多个肺部血管，会导致肺栓塞（PE），肺栓塞可导致猝死（sudden death）。

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：U.S. FDA Approves Eliquis® (apixaban) To Reduce The Risk Of Blood Clots Following Hip Or Knee Replacement Surgery

PRINCETON, N.J. & NEW YORK--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) approved a Supplemental New Drug Application (sNDA) for Eliquis (apixaban) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.

“Today’s FDA approval of Eliquis for DVT prophylaxis in patients who have undergone hip or knee replacement is a significant milestone for this important medicine, which is also approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation,” said Brian Daniels, M.D., senior vice president, global development and medical affairs, Bristol-Myers Squibb. “This approval reflects the continued commitment of the alliance to deliver new treatment options for patients and physicians.”

“As the number of hip and knee replacement surgeries performed in the U.S. continues to increase, the risk of DVT following these surgeries remains a concern for physicians,” said Steven J. Romano, M.D., senior vice president and Medicines Development Group Head, Global Innovative Pharmaceuticals Business, Pfizer Inc. “Eliquis provides patients and physicians with a new treatment option that offers twice daily oral dosing and no routine coagulation testing, and is broadly accessible through hospitals and managed health care formularies.”

The full Prescribing Information for Eliquis includes Boxed Warnings for the increased risk of stroke in patients with nonvalvular atrial fibrillation who discontinue Eliquis without adequate continuous anticoagulation; and for the increased risk of epidural or spinal hematoma, which may cause long-term or permanent paralysis, in patients using Eliquis and undergoing spinal epidural anesthesia or spinal puncture. Please see complete Boxed Warnings and additional Important Safety Information in this press release.

DVT, a blood clot that forms in a large vein, usually in the lower leg, thigh, or pelvis, can lead to PE when a portion or all of a blood clot breaks off and travels to the lungs, blocking one or more blood vessels. PE can lead to sudden death.

Based on recent data, each year in the U.S. an estimated 719,000 total knee replacement surgeries and 332,000 hip replacement surgeries are performed. Patients undergoing hip or knee replacement surgery without thromboprophylaxis are at risk for developing DVT and PE. Guidelines recommend the use of anticoagulants for the prophylaxis of DVT and PE for most patients undergoing orthopedic surgery.

“DVT, which may lead to PE, is a serious medical condition,” said Richard J. Friedman, M.D., FRCSC, Professor of Orthopaedic Surgery, Medical University of South Carolina. “The FDA approval of Eliquis gives U.S. orthopedic surgeons a new option for DVT prophylaxis in both hip and knee replacement surgery.”

This sNDA approval for Eliquis is supported by three clinical trials (the ADVANCE clinical trial program). The ADVANCE trials randomized more than 11,000 patients, with 5,770 receiving Eliquis and 5,755 receiving enoxaparin, to assess the safety and efficacy of Eliquis.

In December 2013, the FDA accepted for review another sNDA for Eliquis for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE.

INDICATION

ELIQUIS is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

ELIQUIS is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.

(责任编辑：lishuheng)