Comments Submitted to the FDA Regarding the Biologics License Application for Teplizumab for Delaying of Type 1 Diabetes Mellitus in At-Risk Individuals

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Public Citizen urged the Food and Drug Administration (FDA) not to approve the biologics license application for teplizumab for the proposed indication for the delay of clinical type 1 diabetes mellitus in at-risk individuals because of the lack of substantial evidence of efficacy, concerns about safety, and a lack of biocomparability between the product studied in clinical trials and the one that is intended for commercial use.