勃林格殷格翰(Boehringer Ingelheim)6月6日宣布,Pradaxa(dabigatran,达比加群酯)获欧盟委员会(EC)批准,用于治疗和预防深静脉血栓(DVT)和肺栓塞(PE)的复发。
Pradaxa是一种简单的治疗选择,疗效与华法林相当,但能够显著降低出血发生率,对DVT和PE患者群体而言是一个重大进步。
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。
此前,FDA已于今年4月批准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。目前,急性VTE患者的标准护理是抗凝治疗。
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。
英文原文:Pradaxa® gains EU approval for treatment and prevention of recurrence of deep vein thrombosis and pulmonary embolism
Pradaxa® is a simple treatment option that is as effective as warfarin with significantly lower bleeding rates, a major advance for DVT and PE patients
EU approval follows recent U.S. FDA approval of Pradaxa® in DVT and PE and increases access to a treatment with proven protective benefits
New approval makes Pradaxa® one of the most broadly indicated novel oral anticoagulants
Ingelheim, Germany, 6 June, 2014 – Boehringer Ingelheim today announces that Pradaxa® (dabigatran etexilate) has been approved by the European Commission for the treatment and prevention of recurrence of deep vein thrombosis (DVT) and pulmonary embolism (PE).1 The U.S. Food and Drug Administration (FDA) approved Pradaxa® for DVT and PE patients earlier this year.5 DVT and PE can be very dangerous; almost one in three PE patients dies within three months and four out of 10 patients suffer a repeat blood clot within 10 years of the first.
"We are delighted with the European Commission’s decision to approve Pradaxa® for DVT and PE patients, confirming the well-studied efficacy and safety profile of Pradaxa®, which has been established in a clinical trial programme in close to 10,000 patients for DVT and PE, and over 40,000 patients across different indications," commented Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim. "Access to this new treatment option is critical for patients as we know that PE as a consequence of a DVT is still the leading cause of preventable death in hospital."
The approval by the European Commission follows the positive opinion issued by the Committee for Medicinal Products for Human Use of the European Medicines Agency, and is based on results from three robust phase III clinical trials that demonstrated the efficacy of Pradaxa® in the treatment and prevention of repeat DVT and PE compared to warfarin.2–4 In a fourth trial, data showed a 92% reduction in the risk of recurrent blood clots in patients treated with Pradaxa® compared to placebo.4 With regards to safety, results showed that DVT or PE patients taking Pradaxa® experienced significantly lower rates of bleeding than those taking warfarin, resulting in a favourable overall safety profile.2–4 Pradaxa® has the longest clinical trial experience in DVT and PE patients of any novel oral anticoagulant (NOAC).4, 10–15
"This approval for dabigatran is a major advance for DVT and PE patients and their physicians," said Professor Dr. Stavros Konstantinides, Deputy Scientific Director of the Centre for Thrombosis and Haemostasis of Johannes Gutenberg University, Mainz, Germany. "Clinical trial results show that dabigatran has a favourable safety profile compared to warfarin, while offering similar efficacy for the treatment and prevention of recurrence of DVT and PE. The added benefits of convenience and a simple fixed dose regimen will appeal to patients and their physicians alike."
Pradaxa® is convenient for patients as it does not require routine dose monitoring, nor a mandatory dose change during the course of treatment. DVT and PE patients can start taking Pradaxa® in a simple fixed dose regimen after initial treatment with an injectable anticoagulant such as low-molecular-weight heparin (LMWH). 1
Clinical experience of Pradaxa® equates to over 2.9 million patient-years in all licensed indications worldwide. 16 Pradaxa® has already been available for more than six years and is approved in over 100 countries to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF).1,16 Pradaxa® 150mg bid is the only NOAC, study of which (RE-LY®) has shown a significant reduction in the incidence of both ischaemic and haemorrhagic strokes versus warfarin in patients with NVAF.17,18 Ischaemic strokes, which account for nine out of 10 strokes experienced by patients with AF, can have devastating consequences and are often fatal or severely disabling.19,20 RE-LY® was a global, phase III, PROBE (prospective, randomized, open-label with blinded endpoint evaluation) design trial comparing two fixed doses of the oral direct thrombin inhibitor Pradaxa® (110mg and 150mg bid) each administered in a blinded manner, with open label warfarin.17,18,21 Pradaxa® 110mg bid, which is indicated for certain patients, showed non-inferior efficacy versus warfarin for reducing risk of stroke.1,17,18 Pradaxa® is also approved for primary prevention of VTE (venous thromboembolism, the collective term for DVT and PE) in patients who have undergone elective total hip or total knee replacement surgery