尼莫利珠单抗：首次获批。

IF 13 1区医学 Q1 PHARMACOLOGY & PHARMACY

Drugs Pub Date : 2022-07-01 Epub Date: 2022-07-14 DOI:10.1007/s40265-022-01741-z

Susan J Keam

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引用次数: 11

摘要

Nemolizumab是一种皮下给药的人源化抗白细胞介素31 (IL-31)受体a (IL-31RA)单克隆抗体，由Chugai制药有限公司、Maruho有限公司和Galderma Pharma S.A.开发，用于治疗皮肤疾病，包括特应性皮炎(AD)、AD相关瘙痒症(ADaP)、结节性痒疹(PN)、慢性肾脏疾病相关瘙痒症(CKDaP)和系统性硬化症(SSc)。IL-31是一种神经免疫细胞因子，在慢性瘙痒性皮肤病中诱导瘙痒、炎症、角化细胞分化和成纤维细胞活化。Nemolizumab (Mitchga®Syringes)于2022年3月28日在日本被批准用于成人和13岁以上儿童，用于治疗与AD相关的瘙痒(仅当现有治疗不够有效时)。本文总结了nemolizumab首次获批的发展里程碑。

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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Nemolizumab: First Approval.

Nemolizumab is a subcutaneously administered humanized anti-interleukin-31 (IL-31) receptor A (IL-31RA) monoclonal antibody that is being developed by Chugai Pharmaceutical Co. Ltd, Maruho Co. Ltd and Galderma Pharma S.A. for the treatment of skin diseases, including atopic dermatitis (AD), AD associated pruritus (ADaP), prurigo nodularis (PN), chronic kidney disease associated pruritus (CKDaP) and systemic sclerosis (SSc). IL-31 is a neuroimmune cytokine that induces itch, inflammation, keratinocyte differentiation and fibroblast activation in chronic pruritic skin diseases. Nemolizumab (Mitchga^® Syringes) was approved in Japan on 28 March 2022 for use in adults and children over the age of 13 years for the treatment of itch associated with AD (only when existing treatment is insufficiently effective). This article summarizes the milestones in the development of nemolizumab leading to this first approval.

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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.