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Teplizumab: First Approval

Susan J Keam1

  • 1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.

Drugs
|March 6, 2023
PubMed

Teplizumab (teplizumab-mzwv; TZIELD™) is a CD3-directed monoclonal antibody (humanized IgG1κ) 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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