Teplizumab: First Approval

被引：26

作者：

Keam, Susan J. ^{[1
]}

机构：

[1] Springer Nat, Private Bag 65901, Auckland 0754, New Zealand

来源：

DRUGS | 2023年 / 83卷 / 05期

关键词：

C-PEPTIDE RESPONSES; TYPE-1; ANTIBODY; TRIAL;

D O I：

10.1007/s40265-023-01847-y

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Teplizumab (teplizumab-mzwv; TZIELD (TM)) is a CD3-directed monoclonal antibody (humanized IgG1 kappa) that is being developed by Provention Bio, Inc. for the treatment of type 1 diabetes (T1D). In November 2022, teplizumab was approved in the USA to delay the onset of Stage 3 T1D in adults and pediatric patients 8 years of age and older with Stage 2 T1D, based on results of a clinical trial in high-risk relatives of individuals with T1D. This article summarizes the milestones in the development of teplizumab leading to this first approval in the treatment of T1D.

引用

页码：439 / 445

页数：7

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