The US FDA has accepted for priority review Sanofi’s supplemental biologic license application (sBLA) for Tzield (teplizumab-mzwv), aiming to expand its use to children as young as one year old. 

 

Currently approved for patients eight and older, Tzield could now be used to delay the onset of stage 3 type 1 diabetes (T1D) in children diagnosed with stage 2 T1D. The FDA’s target decision date is April 29, 2026.

 

“This priority review emphasizes the urgent need for innovative therapies like Tzield which has the potential to prevent the natural progression of T1D by delaying the loss of endogenous insulin production. This might be particularly significant in this young population, as it is well documented that the autoimmune attack that drives this disease in many cases, begins, early in life,” said Christopher Corsico, Global Head of Development at Sanofi.

 

“If approved, Tzield could represent an important advance for delaying the onset of stage 3 type 1 diabetes in early childhood, which would benefit patients and caregivers alike,” he added.

 

The application is supported by positive interim one-year data from the ongoing PETITE-T1D phase 4 study (NCT05757713), which is evaluating the safety and pharmacokinetics of Tzield in young children.

 

PETITE-T1D is an ongoing phase 4, single-arm, open-label, multicenter study assessing Tzield in children under eight diagnosed with stage 2 T1D. Stage 2 is defined by the presence of two or more T1D-related autoantibodies and dysglycemia.

 

The study has enrolled 23 participants, who receive daily intravenous infusions of Tzield for 14 consecutive days. Each participant may be followed for up to 26 months for safety and monitoring.