US FDA advisory committee votes benefits of teplizumab outweigh risks, supporting approval to delay clinical type 1 diabetes (CT1D)

Teplizumab is an investigational anti-CD3 monoclonal antibody under Priority Review by the FDA for the delay of CT1D in at-risk individuals. The positive recommendation (10 yes versus 7 no) was based on data from the TN-10 study (delay of CT1D by a median of at least 2 years).

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