Lebrikizumab：首次批准。

IF 13 1区医学 Q1 PHARMACOLOGY & PHARMACY

Drugs Pub Date : 2024-03-01 DOI:10.1007/s40265-024-02000-z

Susan J Keam

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引用次数: 0

摘要

Lebrikizumab（Ebglyss®）是一种皮下注射的重组人源化IgG4抗IL-13单克隆抗体，由Almirall S.A.和礼来公司共同开发，用于治疗特应性皮炎（AD）。2023 年 11 月，来曲珠单抗在欧盟获批用于治疗中重度特应性皮炎，适用于 12 岁及以上、体重不低于 40 千克、可接受全身治疗的成人和青少年。英国和日本分别于 2023 年 12 月和 2024 年 1 月批准 Lebrikizumab 用于相同的适应症。在美国、瑞士和澳大利亚，Lebrikizumab 正在接受治疗 AD 的监管审查。本文总结了来布利珠单抗开发过程中的里程碑事件，这些事件促成了来布利珠单抗首次获批用于治疗注意力缺陷障碍。

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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Lebrikizumab: First Approval.

Lebrikizumab (Ebglyss^®) is a subcutaneous recombinant humanized IgG4 anti-IL-13 monoclonal antibody developed by Almirall S.A. and Eli Lilly and Company for the treatment of atopic dermatitis (AD). In November 2023, lebrikizumab was approved in the EU for the treatment of moderate-to-severe AD in adults and adolescents 12 years and older with a body weight of at least 40 kg who are candidates for systemic therapy. Lebrikizumab was approved for the same indication in the UK in December 2023 and in Japan in January 2024. Lebrikizumab is under regulatory review for the treatment of AD in the USA, Switzerland and Australia. This article summarizes the milestones in the development of lebrikizumab leading to this first approval for AD.

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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.