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特罗替珠单抗:首次获批

Teprotumumab: First Approval.

机构信息

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

出版信息

Drugs. 2020 Apr;80(5):509-512. doi: 10.1007/s40265-020-01287-y.

Abstract

Teprotumumab (teprotumumab-trbw; TEPEZZA™ - Horizon Therapeutics) is a monoclonal antibody insulin-like growth factor-I receptor (IGF-IR) antagonist developed for the treatment of thyroid eye disease (Graves ophthalmopathy/orbitopathy, thyroid-associated ophthalmopathy). Based on positive results from two multinational clinical trials teprotumumab was recently approved for this indication in the US. This article summarizes the milestones in the development of teprotumumab leading to this first approval for thyroid eye disease.

摘要

特普替尼(teprotumumab-trbw;TEPEZZA ™-Horizon Therapeutics)是一种单克隆抗体胰岛素样生长因子-I 受体(IGF-IR)拮抗剂,用于治疗甲状腺眼病(格雷夫斯眼病/眼眶病、甲状腺相关眼病)。基于两项多中心临床试验的积极结果,特普替尼最近在美国获得了该适应证的批准。本文总结了特普替尼开发过程中的重要里程碑,最终使其获得了甲状腺眼病的首个批准。

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