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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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Novel clinical evidence in continuous glucose monitoring

Novel clinical evidence in continuous glucose monitoring

How real-world studies complement randomized controlled trials

Jean-Pierre Riveline uses data from real-life continuous glucose monitoring studies to illustrate how these can uncover critical information about clinical outcomes that are hard to assess in randomized controlled trials.

This video has been developed through unrestricted educational funding from Abbott Diabetes Care.

Watch the video