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In the context of Teplizumab & Type 1 Diabetes, the U.S. Food and Drug Administration (FDA) approved the pharmacotherapy teplizumab on November 17, 2022. This approval followed a priority review, and the FDA granted a breakthrough therapy designation for its use (1, 4).
The European Medicines Agency (EMA) has not yet granted a final marketing authorisation for teplizumab. However, the Committee for Medicinal Products for Human Use (CHMP) of the EMA has issued a positive opinion recommending EU-wide approval for teplizumab for stage 2 type 1 diabetes. Therefore, formal Commission approval is anticipated but remains pending as of late 2025.
Relatives of individuals …