The US Food and Drug Administration (FDA) has accepted for priority review the supplemental biologic license application (sBLA) for Tzield (teplizumab-mzwv), seeking to expand its approved age indication to include children as young as one year old. The expanded label would allow the therapy to be used to delay the onset of stage 3 type 1 diabetes (T1D) in patients diagnosed with stage 2 T1D.

The sBLA is supported by positive interim one-year data from the ongoing PETITE-T1D Phase 4 study, which is evaluating the safety and pharmacokinetics of Tzield in young children. The FDA has set a target action date of April 29, 2026.

Christopher Corsico, Global Head of Development, Sanofi, stated, “Delaying the loss of endogenous insulin production could be especially impactful in early childhood, when autoimmune activity often begins.” 

Tzield is a CD3-directed monoclonal antibody and the first disease-modifying therapy approved to delay the onset of stage 3 type 1 diabetes. It received its first US approval in November 2022 for adults and children aged eight years and older with stage 2 T1D. The therapy is also approved in several global markets, including China, the UK, Canada and parts of the Middle East, with additional regulatory reviews ongoing.

The priority review designation highlights the unmet need for therapies that can alter the course of autoimmune type 1 diabetes, particularly in very young patients. By intervening earlier in the disease course, Tzield aims to delay progression and reduce the long-term burden on patients and caregivers.