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11-18-2022 | Teplizumab | News

approvalsWatch

FDA clearance for teplizumab to slow type 1 diabetes onset

Author: Eleanor McDermid

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medwireNews: The monoclonal antibody teplizumab has been approved by the US FDA to delay the onset of stage 3 type 1 diabetes in adults and children aged at least 8 years.

The medication, which is given as a single 14-day course of daily intravenous infusions, is to be used in people with stage 2 diabetes, ie, those who have islet autoantibodies and evidence of dysglycemia, but do not yet meet the criteria for a clinical diagnosis of type 1 diabetes.

Teplizumab is an anti-CD3 antibody, which modifies CD8+ T lymphocytes. In a phase 2 placebo-controlled clinical trial it nearly doubled the median time to diabetes diagnosis, and an extended follow-up of the trial population revealed sustained preservation of beta-cell function.

medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2022 Springer Healthcare Ltd, part of the Springer Nature Group

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