Sanofi announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review its supplemental Biologics License Application (sBLA) for Tzield (teplizumab-mzwv) targeting young children with stage 2 type 1 diabetes.
The healthcare group aims to expand the current age indication, which is 8 years and older, to include children as young as 1 year old, in order to delay the onset of stage 3 type 1 diabetes (T1D) in patients diagnosed with stage 2 T1D.
This sBLA is supported by positive one-year interim data from the ongoing phase 4 PETITE-T1D study, which is evaluating the safety and pharmacokinetics of Tzield in young children. The target action date for the FDA’s decision is April 29, 2026.
Priority review is granted to regulatory applications seeking approval for treatments that may offer significant improvements in the treatment, diagnosis, or prevention of serious conditions.
If Sanofi’s application is approved, Tzield would become the first disease-modifying therapy to delay the onset of stage 3 type 1 diabetes in children aged one year and older who have been diagnosed with stage 2 type 1 diabetes.
