Nipocalimab：首次批准。

IF 14.4 1区医学 Q1 PHARMACOLOGY & PHARMACY

Drugs Pub Date : 2025-09-01 Epub Date: 2025-08-08 DOI:10.1007/s40265-025-02211-y

Simon Fung

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引用次数: 0

摘要

Nipocalimab (nipocalimab-aahu;IMAAVY™)是一种全人源单克隆抗体，结合并阻断新生儿片段结晶（Fc）受体（FcRn），导致循环IgG水平降低。它是由强生公司开发的，用于治疗多种自身免疫性疾病。2025年4月29日，nipocalimab在美国首次获得批准，用于治疗抗乙酰胆碱受体或抗肌肉特异性酪氨酸激酶抗体阳性的成人和儿童患者的全身性重症肌无力。nipocalimab治疗广泛性重症肌无力的监管审查正在日本和欧盟进行。本文总结了nipocalimab首次被批准用于治疗广泛性重症肌无力的发展历程。

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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Nipocalimab: First Approval.

Nipocalimab (nipocalimab-aahu; IMAAVY™) is a fully human monoclonal antibody that binds to and blocks the neonatal fragment crystallizable (Fc) receptor (FcRn) resulting in the reduction of circulating IgG levels. It is being developed by Johnson & Johnson for the treatment of a number of autoimmune disorders. On 29 April 2025, nipocalimab received its first approval in the USA for the treatment of generalized myasthenia gravis in adult and pediatric patients ≥ 12 years of age who are anti-acetylcholine receptor or anti-muscle specific tyrosine kinase antibody positive. Regulatory review of nipocalimab is underway for generalized myasthenia gravis in Japan and the European Union. This article summarizes the milestones in the development of nipocalimab leading to this first approval for generalized myasthenia gravis.

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来源期刊

Drugs 医学-毒理学

CiteScore

22.70

自引率

0.90%

发文量

134

审稿时长

3-8 weeks

期刊介绍： Drugs is a journal that aims to enhance pharmacotherapy by publishing review and original research articles on key aspects of clinical pharmacology and therapeutics. The journal includes: Leading/current opinion articles providing an overview of contentious or emerging issues. Definitive reviews of drugs and drug classes, and their place in disease management. Therapy in Practice articles including recommendations for specific clinical situations. High-quality, well designed, original clinical research. Adis Drug Evaluations reviewing the properties and place in therapy of both newer and established drugs. AdisInsight Reports summarising development at first global approval. Moreover, the journal offers additional digital features such as animated abstracts, video abstracts, instructional videos, and podcasts to increase visibility and educational value. Plain language summaries accompany articles to assist readers with some knowledge of the field in understanding important medical advances.