Sanofi’s Tzield accepted for expedited review in the US for stage 3 type 1 diabetes through FDA Commissioner's National Priority Voucher pilot program

Sanofi

20 October 2025 - The US FDA has accepted for expedited review the supplemental biologics license application for Tzield (teplizumab-mzwv) to delay the progression of stage 3 type 1 diabetes in adults and paediatric patients eight years of age and older recently diagnosed with stage 3 type 1 diabetes. 

The FDA nominated Tzield for the Commissioner's National Priority Voucher pilot program based on its potential to address a large unmet medical need.

Read Sanofi press release

Michael Wonder

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Michael Wonder

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Medicine , US , Priority review , Dossier