RD Insight, Wolters Kluwer Pharma Solutions, Auckland, New Zealand.
Drugs. 2011 Oct 22;71(15):2079-89. doi: 10.2165/11596820-000000000-00000.
Apixaban (Eliquis™), an oral direct factor Xa inhibitor, is being developed by Bristol-Myers Squibb and Pfizer as a therapy for the prevention and/or treatment of thrombotic disorders. Apixaban has been approved in the EU for the prevention of venous thromboembolism (VTE) after hip or knee replacement. A rolling submission for approval of apixaban for the prevention of stroke in patients with atrial fibrillation has also been initiated in the US. Worldwide phase III development of apixaban is underway for the prevention and treatment of VTE, and prevention of stroke in patients with atrial fibrillation. Development for acute coronary syndromes has been stopped following the discontinuation of the phase III APPRAISE-II trial. This article summarizes the milestones in the development of apixaban leading to this first approval for the prevention of VTE after hip or knee replacement.
阿哌沙班（艾乐妥），一种口服直接因子 Xa 抑制剂，由百时美施贵宝和辉瑞公司开发，用于预防和/或治疗血栓性疾病。阿哌沙班已在欧盟获批用于髋关节或膝关节置换术后预防静脉血栓栓塞症（VTE）。在美国，也已启动滚动提交阿哌沙班用于预防心房颤动患者中风的申请。阿哌沙班在全球范围内进行着 III 期临床试验，用于预防和治疗 VTE，以及预防心房颤动患者的中风。在 APPRAISE-II 三期临床试验停止后，其用于急性冠脉综合征的研发也已停止。本文总结了阿哌沙班的研发里程碑，最终使其在髋关节或膝关节置换术后 VTE 的预防方面获得了首次批准。
