FDA批准达比加群酯用于深静脉血栓形成和肺动脉栓塞

【FDA批准达比加群酯用于深静脉血栓形成和肺动脉栓塞】勃林格殷格翰公司在本月7号宣布，FDA已批准达比加群酯用于已接受抗凝注射液治疗5~10天的DVT和PE患者。重要依据为4项国际临床3期研究的效果。达比加群酯于2008年在德国和英国上市，是继华法林之后50年来首个上市的抗凝血口服新药，是里程碑式药物

勃林格殷格翰抗凝血剂Pradaxa新适应症获FDA批准
作者：tomato来源：生物谷2014-4-8 7:45:07
关键词： 勃林格殷格翰 抗凝血剂 Pradaxa 达比加群酯 深静脉血栓



2014年4月7日讯 /生物谷BIOON/ --勃林格殷格翰（Boehringer Ingelheim）4月7日宣布，FDA已批准Pradaxa（dabigatran，达比加群酯）用于已接受5-10天肠外抗凝剂（parenteral anticoagulant）的患者，治疗深静脉血栓（DVT）和肺栓塞（PE），以及用于既往已治疗过的患者，降低DVT和PE复发的风险。

深静脉血栓（DVT）和肺栓塞（PE）统称为静脉血栓栓塞（VTE），是继冠状动脉疾病、中风之后的第3种最常见心血管疾病。在美国，每年约有90万例VTE事件，其中约1/3患者死于PE。此外，大约有1/3的VTE患者会在10年内复发。目前，急性VTE患者的标准护理是抗凝治疗。

Pradaxa新适应症的获批，是基于4项全球性III期临床研究（RE-COVER I,RE-COVER II,RE-MEDY,RE-SONATE），这些研究评价了Pradaxa治疗VTE的疗效和安全性。

目前，Pradaxa已获FDA批准，用于非瓣膜性心房颤动（NVAF）患者减少中风和全身性栓塞风险，该药是过去50多年来，获FDA批准用于该适应症的首个口服抗凝血剂。

关于Pradaxa （dabigatran，达比加群酯）：

达比加群酯（Dabigatran）是德国勃林格殷格翰公司开发的新型抗凝血药物。该药于2008年4月首先在德国和英国上市，商品名为Pradaxa。这是继华法林之后50年来首个上市的抗凝血口服新药，是抗凝血治疗领域和潜在致死性血栓预防领域的又一个里程碑。

达比加群酯具有口服、强效、无需特殊用药监测、药物相互作用少等特点。体外、体内试验和临床各项研究均提示本品具有良好的疗效及药动学特性，临床应用前景乐观，对预防深静脉血栓和肺动脉栓塞有较好的作用。其成功上市是抗凝血药物研究领域的一项重大突破。

2008年，欧洲和加拿大已批准达比加群酯用于防治急性静脉血栓（VTE）。目前，达比加群酯适应证还包括关节置换术后血栓形成的预防及房颤患者预防中风。全球每年约300万人罹患房颤相关性卒中，这一情况日趋严重，并且患者的致残率明显上升，其中约半数患者在一年内死亡。研究表明，达比加群酯不但可以提供良好的卒中预防作用，而且出血风险较少并且无需常规监测。

Pradaxa的竞争对手包括拜耳和强生公司的拜瑞妥（Xarelto）及施贵宝公司和辉瑞公司的Eliquis。（生物谷bioon.com）

英文原文：FDA Approves Pradaxa® (dabigatran etexilate mesylate) for Treatment and Reduction in the Risk of Recurrence of Deep Venous Thrombosis and Pulmonary Embolism

The US Food and Drug Administration has approved German family-owned pharma major Boehringer Ingelheim’s Pradaxa (dabigatran etexilate mesylate) for additional indications, the firm’s US subsidiary announced today.

The FDA cleared Pradaxa for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for five to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated. DVT and PE are collectively referred to as venous thromboembolism (VTE). There are an estimated 900,000 DVT and PE events per year in the USA, around one-third of which result in death from PE.

Approved in 2010, Pradaxa generated sales of 612 million euros ($811 million) in the first half of 2013, up nearly 28%, for Boehringer, which has yet to report its 2013 financial results. The drug is currently approved by the FDA to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF), and was the first oral anticoagulant approved by the FDA in more than 50 years for this indication.

"Venous thromboembolism is the third most common cardiovascular disease after myocardial infarction and stroke. About one-third of patients with a DVT or PE will suffer a recurrence within 10 years," said Samuel Goldhaber, Director of Brigham and Women's Hospital's Thrombosis Research Group and Professor of Medicine, Harvard Medical School, adding: "Dabigatran has established efficacy and safety for stroke risk reduction in patients with non-valvular atrial fibrillation. This new FDA approval expands dabigatran's indications to include treatment and the reduction of the risk of recurrence of DVT and PE."

The approval is based on results from four global Phase III studies evaluating the efficacy and safety of Pradaxa in the treatment of DVT and PE. Three pivotal trials showed Pradaxa as non-inferior to warfarin in reduction of DVT and PE recurrence; a fourth pivotal trial showed Pradaxa reduced risk of recurrence by 92% compared to placebo.

(责任编辑：lishuheng)