FDA《狂犬病:为暴露后预防的被动免疫成分研制单克隆抗体鸡尾酒供企业用指导原则》介绍  

Introduction to FDA's Rabies:Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis Guidance for Industry

作　　者：萧惠来 XIAO Huilai(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022

出　　处：《药物评价研究》2021年第10期2134-2143,共10页Drug Evaluation Research

摘　　要：狂犬病是由狂犬病毒引起的急性传染病,及时给予暴露后预防(PEP)可阻止临床症状出现。PEP由清洗伤口、给予狂犬病疫苗和在伤口内和周围给予抗狂犬病病毒免疫球蛋白(RIG)3部分构成。由于多种原因限制了RIG的使用,其全球使用率不到狂犬病病毒暴露的2%。因此,抗狂犬病病毒单克隆抗体鸡尾酒正被开发为PEP被动免疫成分RIG的替代品。美国食品药品监督管理局(FDA)于2021年7月发布了《狂犬病:为暴露后预防的被动免疫成分研制单克隆抗体鸡尾酒供企业用指导原则》,旨在促进抗狂犬病病毒单克隆抗体鸡尾酒的开发,并对抗狂犬病病毒单克隆抗体鸡尾酒的研究提出了详细而具体的建议,其中包括临床和非临床研究的要点以及临床Ⅲ期疗效试验设计。详细介绍该指导原则主要内容,期望对中国在此方面的研究和监管提供帮助,对《抗狂犬病病毒单克隆抗体新药临床试验技术指导原则(征求意见稿)》的修订有所启示。Rabies is an acute infectious disease caused by rabies virus, timely administration of rabies post-exposure prophylaxis(PEP) is effective in preventing clinical rabies. PEP consists of washing the wound, administrating rabies vaccine and administrating anti rabies virus immunoglobulin(RIG) in and around the wound. Due to various reasons, the use of RIG is limited, and its global use rate is less than 2% of rabies virus exposure. Therefore, anti-rabies virus monoclonal antibody cocktails are being developed as an alternative to RIG as the passive immunization component of PEP. FDA issued Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis Guidance for Industry in July 2021, which aims to promote the development of monoclonal antibody cocktails against rabies virus. The guidelines put forward many detailed and specific suggestions for the study of monoclonal antibody cocktail against rabies virus, including the key points of clinical and non clinical research and the design of clinical phase Ⅲ efficacy trial. This article details the guidelines, expected to be helpful to China’s research and supervision in this regard. It also has enlightenment for the revision of Technical Guidence for Clinical Trials of New Anti-Rabies Virus Monoclonal Antibodies(Draft) in China.

关 键 词：美国食品药品管理局 狂犬病 病毒 暴露后预防 被动免疫 单克隆抗体 指导原则 

分 类 号：R951[医药卫生—药学]