2013年8月29日讯 --勃林格殷格翰（Boehringer Ingelheim）8月28日宣布，FDA已接受审查Pradaxa（dabigatran，达比加群酯）用于深静脉血栓（DVT）和肺栓塞（PE）患者治疗的补充新药申请（sNDA）。
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补充新药申请的提交，是基于4项全球性III期临床研究（RE-COVER I,RE-COVER II,RE-MEDY,RE-SONATE），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。
据勃林格殷格翰数据，Pradaxa在2013年上半年的全球销售达到了7.96亿美元。
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。
FDA Accepts Boehringer Ingelheim's Supplemental New Drug Application for Use of Dabigatran Etexilate Mesylate in Deep Vein Thrombosis and Pulmonary Embolism
RIDGEFIELD, Conn., Aug. 28, 2013 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for Pradaxa? (dabigatran etexilate mesylate) for its use in patients with deep vein thrombosis (DVT) and pulmonary embolism (PE).
DVT and PE are collectively referred to as venous thromboembolism (VTE), which is the third most common cardiovascular disorder after coronary artery disease and stroke. A DVT occurs when a blood clot develops in a deep vein, usually in the leg or pelvis, and either partially or totally blocks the flow of blood through the vein. A PE occurs when a DVT, or part of it, breaks off, and travels through the bloodstream to the lungs, blocking a vessel. This is considered a life-threatening condition. There are an estimated 900,000 VTE events per year in the U.S., approximately one-third of which result in death from PE. Further, roughly one-third of people with VTE will have a recurrence within 10 years. The standard of care for patients with acute VTE is anticoagulation.
"Boehringer Ingelheim is committed to addressing the complex medical need of patients with deep vein thrombosis and pulmonary embolism," said Sabine Luik, M.D., senior vice president, Medicine & Regulatory Affairs, U.S. Regional Medical Director, Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI). "We look forward to discussing with the FDA dabigatran's use in these two potentially life-threatening conditions."
The sNDA is based on results from four global Phase III studies evaluating the efficacy and safety of dabigatran in the treatment of this condition, specifically RE-COVER? I and II, RE-MEDY(SM) and RE-SONATE?.
Pradaxa 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.
Prescribing experience with Pradaxa continues to grow with more than 6 million prescriptions for Pradaxa 150mg and 75mg filled for more than 800,000 NVAF patients in the U.S. since its approval in October of 2010. Pradaxa is included on formularies that insure about 95 percent of covered lives in the U.S., through commercial and Medicare Part D plans. Pradaxa is also included in recommendations from three leading U.S. cardiology guidelines for stroke prevention in AFib.
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