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安斯福姆单抗：首次批准。

Ansuvimab: First Approval.

机构信息

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

出版信息

Drugs. 2021 Apr;81(5):595-598. doi: 10.1007/s40265-021-01483-4. Epub 2021 Mar 22.

DOI:10.1007/s40265-021-01483-4
PMID:33751449
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7983082/
Abstract

Ansuvimab (ansuvimab-zykl; EBANGA™) is a human monoclonal antibody developed by Ridgeback Biotherapeutics, which binds to the glycoprotein on Zaire ebolavirus (Ebola virus) to block its entry into host cells. Ansuvimab has been recently approved in the USA for the treatment of infection caused by Z. ebolavirus in adult and paediatric patients, including in neonates born to a mother who is RT-PCR positive for Z. ebolavirus infection, following the results of the PALM phase II/III trial. This article summarizes the milestones in the development of ansuvimab leading to this first approval for the treatment of infections caused by Ebola virus in adults and paediatric patients.

摘要

安斯福姆单抗（ansuvimab-zykl；EBANGA™）是由 Ridgeback Biotherapeutics 开发的一种人源单克隆抗体，它与扎伊尔埃博拉病毒（Ebola virus）上的糖蛋白结合，阻止其进入宿主细胞。安斯福姆单抗最近在美国获得批准，用于治疗成人和儿科患者感染扎伊尔埃博拉病毒，包括母亲埃博拉病毒 RT-PCR 检测阳性的新生儿，这是基于 PALM 二期/三期试验的结果。本文总结了安斯福姆单抗开发过程中的重要里程碑，最终使其首次获批用于治疗成人和儿科患者的埃博拉病毒感染。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/35af/7983082/0f3f589155fa/40265_2021_1483_Figa_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/35af/7983082/0f3f589155fa/40265_2021_1483_Figa_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/35af/7983082/0f3f589155fa/40265_2021_1483_Figa_HTML.jpg

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