Inebilizumab-cdon:美国fda批准用于治疗NMOSD(视神经脊髓炎光谱障碍)。

Q3 Pharmacology, Toxicology and Pharmaceutics

Current drug discovery technologies Pub Date : 2022-01-01 DOI:10.2174/1570163818666210519103001

Faraat Ali, Kamna Sharma, Varisha Anjum, Asad Ali

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引用次数: 2

摘要

Inebilizumab-cdon (Uplizna™)目前已被美国食品和药物管理局(USFDA)批准用于治疗NMOSD(视神经脊髓炎频谱障碍)。它是由Viela Bio (Nasdaq: VIE) USA开发的。Inebilizumab-cdon(原MEDI-551)是一种人源化抗体，通过增加效应细胞的抗体依赖性细胞毒性(ADCC)和细胞吞噬(ADCP)诱导CD19 + B细胞耗竭。各种临床试验显示其安全有效的药代动力学和药效学特征。2019年6月，Viela Bio根据N-Momentum试验的结果向FDA提交了生物制剂许可申请(BLA)。本文总结了Inebilizumab-cdon在治疗晚期NMOSD方面的里程碑式进展。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Inebilizumab-cdon: USFDA Approved for the Treatment of NMOSD (Neuromyelitis Optica Spectrum Disorder).

Inebilizumab-cdon (Uplizna™) was currently approved by the United States Food and Drug Administration (USFDA) for the treatment of NMOSD (neuromyelitis optica spectrum disorder). It was developed by Viela Bio (Nasdaq: VIE) USA. Inebilizumab-cdon (formerly MEDI-551) is a humanized antibody, which induces CD19 + B cell depletion by increasing antibody-dependent cell cytotoxicity (ADCC) and cell phagocytosis (ADCP) of effector cells. Various clinical trials exhibit its safe and effective pharmacokinetic and pharmacodynamic profile. In June 2019, Viela Bio submitted Biologics License Application (BLA) to the FDA based on the findings obtained from the N-Momentum trial. This article summarizes the milestones in the development of Inebilizumab-cdon leading to this approval for the treatment of advanced NMOSD.

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来源期刊

Current drug discovery technologies Pharmacology, Toxicology and Pharmaceutics-Drug Discovery

CiteScore

3.70

自引率

0.00%

发文量

期刊介绍： Due to the plethora of new approaches being used in modern drug discovery by the pharmaceutical industry, Current Drug Discovery Technologies has been established to provide comprehensive overviews of all the major modern techniques and technologies used in drug design and discovery. The journal is the forum for publishing both original research papers and reviews describing novel approaches and cutting edge technologies used in all stages of drug discovery. The journal addresses the multidimensional challenges of drug discovery science including integration issues of the drug discovery process.