达比加群逆转剂获欧洲药品管理局人用医药产品委员会正面评价
● 第一个获得CHMP正面评价的非维生素K口服抗凝药特异性逆转剂
● 正面评价是基于临床研究结果,该结果显示idarucizumab在几分钟之内即可逆转达比加群的抗凝作用
德国殷格翰2015年9月28日电 /美通社/ -- 今天,欧洲药品管理局 (EMA)人用医药产品委员会(CHMP)给予了idarucizumab (将以Praxbind®作为商品名)正面评价,推荐其在欧洲获得批准。若获准,idarucizumab将用于接受泰毕全(达比加群酯)的成人患者需要 急诊手术/介入性操作或者出现危及生命或无法控制的出血并发症时,快速逆转达比加群的抗凝作用。[1]
欧洲心血管协会主席,葡萄牙里斯本大学Fausto J. Pinto教授指出:“CHMP推荐批准idarucizumab的正面评价是抗凝治疗领域的一个重要推荐。非维生素K 口服抗凝药 (NOACs)的诞生已经是抗凝领域的一个重大进步。批准特异性逆转剂来迅速停止这些药物的抗凝作用将是下一个进步。”
欧洲卒中组织主席,英国格拉斯哥大学Kennedy R. Lees教授评论道:“对于那些接受抗凝药物如达比加群治疗的卒中患者来说,这就像是蛋糕上的糖霜:在紧急情况下我们将有可能将他们所接受药物的作用迅速 地、安全地关掉。对医生和患者来说,这将使治疗选择更加容易。”
CHMP正面评价是基于健康受试者的试验数据及RE-VERSE AD™ 研究的期中分析结果。[2-5]在这些研究中,idarucizumab的逆转作用在使用5克该药物后几分钟之内即迅速显现。[2-4]在几乎所有患者中逆转作用完全并且持久。[2-5]没有发现与idarucizumab有关的严重不良反应事件。另外,在使用idarucizumab后未出现促凝作用。[2,5]
“我们的科学家为idarucizumab做了深入而持久的研究,所以现在我们对在欧洲获得批准推荐感到 非常兴奋,”勃林格殷格翰心血管治疗领域医学副总裁Jorg Kreuzer教授说道,“我相信idarucizumab将增加医生和患者选择达比加群的信心,因为达比加群是第一个拥有特异性逆转剂的NOAC。”
Idarucizumab目前处于全球监管部门审批过程中,[6]包括美国FDA。[7]勃林格殷格翰计划在所有达比加群获批的国家递交idarucizumab的上市申请。[6]
更多信息
1. Committee for Medicinal Products for Human Use (CHMP). Minutes from 21-24 September 2015 meeting. Available at:http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/003986/WC500194147.pdf
2. Glund S, et al. Safety, tolerability, and efficacy of idarucizumab for the reversal of the anticoagulant effect of dabigatran in healthy male volunteers: a randomised, placebo-controlled, double-blind phase 1 trial. Lancet. 2015;386:680–690.
3. Glund S. et al. Idarucizumab, a Specific Antidote for Dabigatran: Immediate, Complete and Sustained Reversal of Dabigatran Induced Anticoagulation in Elderly and Renally Impaired Subjects. Oral presentation on 8 December 2014 at The 56th American Society of Hematology Annual Meeting & Exposition, San Francisco, USA. Blood 2014; 124: Abstract 344.
4. Pollack C. V., et al. Idarucizumab for Dabigatran Reversal. NEJM. 2015;373:511-520.
5. Glund S, et al. A randomised study in healthy volunteers to investigate the safety, tolerability and pharmacokinetics of idarucizumab, a specific antidote to dabigatran. Thromb Haemost. 2015;113:943–951.
6. Boehringer Ingelheim data on file.
7. Boehringer Ingelheim Press Release – 03 March 2015. Boehringer Ingelheim submits applications for approval of idarucizumab, specific reversal agent to dabigatran etexilate (Pradaxa®), to EMA, FDA and Health Canada. http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2015/03_march_2015_dabigatranetexilate.html. Last accessed September 2015.
8. Pradaxa® US Prescribing Information, 2015.
9. Boehringer Ingelheim Press Release – 22 May 2015. Antidote for rapid reversal of Pradaxa® (dabigatran etexilate) progresses into next stage of clinical investigation with study in patients. http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2014/22_may_2014_dabigatranetexilate.html Last accessed September 2015.
10. Pollack C. V. et al. Design and rationale for RE-VERSE AD: A phase 3 study of idarucizumab, a specific reversal agent for dabigatran. Thromb Haemost. 2015;114(1):198-20.
11. Pradaxa® European Summary of Product Characteristics, 2015.
12. Stangier J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet. 2008;47(5):285–95.
13. Di Nisio M. et al. Direct thrombin inhibitors. N Engl J Med. 2005;353:1028–40.
14. Stangier J. et al. Pharmacokinetic Profile of the Oral Direct Thrombin Inhibitor Dabigatran Etexilate in Healthy Volunteers and Patients Undergoing Total Hip Replacement. J Clin Pharmacol. 2005;45:555–63.