中国药物警戒 ›› 2017, Vol. 14 ›› Issue (4): 218-221.

• 法规与管理研究 • 上一篇    下一篇

从普纳替尼撤市再上市谈欧美药品风险管理

岳晓萌, 郭心怡, 万敬员, 郭剑非   

  1. 1.辛辛那提大学药学院, 美国俄亥俄州 辛辛那提 45267;
    2.重庆医科大学药学院,重庆 400016
  • 收稿日期:2017-07-05 修回日期:2017-07-05 出版日期:2017-04-20 发布日期:2017-07-05
  • 通讯作者: 郭剑非, 男,博士,终身教授,药物流行病及药物经济学。 E-mail: jeff.guo@uc.edu
  • 作者简介:岳晓萌,女,在读博士,药物经济学及药物流行病。

Ponatinib and Its Risk Management in United States and European Union

YUE Xiao-meng, GUO Xin-yi, WAN Jing-yuan, GUO Jian-fei   

  1. 1.James L. Winkle College of Pharmacy, University of Cincinnati, Cincinnati OH 45267, USA;
    2.College of Pharmacy, Chongqing Medical University, Chongqing 400016,China
  • Received:2017-07-05 Revised:2017-07-05 Online:2017-04-20 Published:2017-07-05

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摘要： 目的 以普纳替尼在美国和欧盟的风险管理评估为范例,为中国创新药物的监测与风险管理提供借鉴与参考。方法 通过使用Medline和其他搜索引擎,系统介绍美国食品药品监督管理局(FDA)的风险评估与减轻策略（REMS）,以及欧盟药品管理局(EMA)在普纳替尼引起的严重致死性心血管类不良事件上的风险管理和处理方式。结果 普纳替尼作为一种激酶抑制剂,被批准用于阳性慢性髓细胞白血病和阳性费城染色体阳性急性淋巴细胞白血病。由于普纳替尼引起的严重不良反应,2013年10月在美国撤市后,经风险评估、限制适应证、添加警示等,2013年12月在安全监控下重返美国市场。欧盟对普纳替尼的风险管理存在类似的风险管理计划。结论 药品风险管理贯穿于药品生命周期的各个阶段,尤其是新药审批、临床试验、上市后再评价与安全监控、甚至是药物撤市、及重新上市等各环节。在创新药物监督管理方面可以借鉴美国食品药品监督管理局和欧盟药品管理局的风险管理计划及策略,为规范我国创新药物的安全管理,完善中国药品监管工作提供良好的借鉴与参考。

关键词: 普纳替尼, 撤市, 重返市场, 风险管理, 风险评估与减轻策略

Abstract: Objective To provide suggestions to conduct risk management and risk evaluation and mitigation strategy in China by describing ponatinib risk management experience in the United States (US) and European Union (EU). Methods Using Medline and other Internet-based search engines, we systematically reviewed ponatinib withdrawal case due to serious vascular occlusion events and its reintroduction into the market under the Risk Evaluation and Mitigation Strategy (REMS) in US. We also reviewed ponatinib risk assessment in European Union. Results Ponatinib (Iclusig®), a kinase inhibitor, was approved for positive chronic myeloid leukemia and positive Philadelphia chromosome positive acute lymphoblastic leukemia. Due to the serious adverse reaction, ponatinib was withdrawn in October 2013. Due to its unique pharmacologic efficacy, it was re-introduced to the market in December 2013 under the unique REMS in US. A similar risk management plan was introduced in EU countries. Conclusion The risk management for pharmaceutical products applies to the life cycle of drug development from Investigational New Drug (IND), New Drug Application (NDA), post-marketing, and even to post-withdrawal and reintroduction. The experience of ponatinib risk management in US and EU might shed some light for the future risk management of drug safety in China.

Key words: ponatinib, withdrawal, reintroduction, risk management, risk evaluation and mitigation strategy

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