Posted by Michael Wonder on 05 Jan 2026
Sanofi’s Tzield accepted for priority review in the US for young children with stage 2 type 1 diabetes
5 January 2026 - The US FDA has accepted for priority review the supplemental biologic license application for Tzield (teplizumab-mzwv) to expand the current age indication from eight years and above, to as young as one year old and above to delay the onset of stage 3 type 1 diabetes mellitus in patients diagnosed with stage 2 type 1 diabetes mellitus.
The supplemental biologic license application is supported by the positive interim one-year data from the on-going PETITE-T1D Phase 4 study, evaluating the safety and pharmacokinetics of Tzield in young children.
The target action date for the FDA decision is 29 April 2026.
