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REGN-EB3:首次批准。

REGN-EB3: First Approval.

机构信息

Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand.

出版信息

Drugs. 2021 Jan;81(1):175-178. doi: 10.1007/s40265-020-01452-3.

Abstract

REGN-EB3 (INMAZEB, Regeneron Pharmaceuticals) is a combination of three fully-human monoclonal antibodies-atoltivimab (REGN3470), maftivimab (REGN3479), and odesivimab (REGN3471) -that target Ebola virus glycoprotein. Based on the results of the PALM study conducted during an Ebola outbreak in the Democratic Republic of Congo, REGN-EB3 was recently approved by the US FDA as a treatment for Ebola virus infection. This article summarizes the milestones in the development of REGN-EB3 leading to this first approval for the treatment of infection caused by Zaire ebolavirus (Ebola virus) in adult and paediatric patients.

摘要

REGN-EB3(INMAZEB,再生元制药公司)是三种完全人源单克隆抗体的组合-阿托利珠单抗(REGN3470)、美他珠单抗(REGN3479)和奥得西珠单抗(REGN3471)-靶向埃博拉病毒糖蛋白。基于在刚果民主共和国埃博拉疫情期间进行的 PALM 研究结果,REGN-EB3 最近被美国 FDA 批准用于治疗埃博拉病毒感染。本文总结了导致这一首次批准用于治疗成人和儿科患者扎伊尔埃博拉病毒(埃博拉病毒)感染的 REGN-EB3 开发过程中的里程碑事件。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d6e6/7799152/fc6de7df0d7a/40265_2020_1452_Figa_HTML.jpg

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