The US Food and Drug Administration (FDA) has accepted Sanofi’s supplemental biologics license application (sBLA) for Tzield (teplizumab-mzwv) for priority review to expand its indication to children aged one year and older with stage 2 type 1 diabetes (T1D). The FDA’s target action date is April 29, 2026.
If approved, Tzield would be the first disease-modifying therapy shown to delay progression to stage 3 T1D in very young children. The therapy works by modulating the immune response to protect insulin-producing pancreatic beta cells, slowing disease progression and postponing the need for insulin therapy.
The sBLA 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 children under eight years with stage 2 T1D. Interim results were presented at the 51st Annual Conference of the International Society for Pediatric and Adolescent Diabetes and published in Diabetologia.
PETITE-T1D is a single-arm, open-label, multicentre study that has enrolled 23 participants. Patients receive once-daily intravenous infusions of Tzield for 14 consecutive days, with follow-up lasting up to 26 months. Stage 2 T1D is defined by the presence of two or more diabetes-related autoantibodies and dysglycaemia, prior to the onset of clinical symptoms.
Tzield is currently approved in the US for adults and children aged eight years and older with stage 2 T1D, and in several other countries for the same indication. Its safety and efficacy in children under eight years have not yet been approved by any regulatory authority.
