Posted by Michael Wonder on 22 Apr 2026
Sanofi's Tzield approved in the US to delay the onset of stage 3 type 1 diabetes in young children
22 April 2026 - The US FDA has approved the supplemental biologic license application for Tzield (teplizumab-mzwv), expanding the indication from eight years and older to as young as one year of age to delay the onset of stage 3 type 1 diabetes in patients diagnosed with stage 2 type 1 diabetes.
The approval was granted under a priority review process and is supported by one year data from the PETITE-T1D Phase 4 study, evaluating safety and pharmacokinetics in young children.
