Teplizumab: First Approval

被引：18
|
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.
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页码：439 / 445
页数：7
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