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.

译文

阿哌沙班 (Eliquis™百时美施贵宝 (Bristol-Myers Squibb) 和辉瑞 (Pfizer) 正在开发一种口服直接因子Xa抑制剂,作为预防和/或治疗血栓性疾病的疗法。阿哌沙班已在欧盟被批准用于预防髋关节或膝关节置换术后静脉血栓栓塞 (VTE)。在美国,还开始了批准阿哌沙班用于预防房颤患者中风的滚动提交。阿哌沙班的全球III期开发正在进行中,用于预防和治疗VTE以及预防房颤患者的中风。终止III期评估-II试验后,急性冠状动脉综合征的发展已停止。本文总结了阿哌沙班发展的里程碑,从而首次批准用于预防髋关节或膝关节置换术后的VTE。

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