Full Press Release Details
Sanofi's Tzield accepted for priority review in the US for young children with stage 2
Paris, January 5, 2026. The US Food and Drug Administration (FDA) has accepted for priority
review the supplemental biologic license application (sBLA) 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 (T1D) in
patients diagnosed with stage 2 T1D. The sBLA is supported by the positive interim one-year data from the ongoing PETITE-T1D phase 4 study (clinical study identifier: NCT05757713), evaluating the safety and pharmacokinetics of Tzield in young children. The target action date for the FDA decision is
"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."
Interim data for the
PETITE-T1D phase 4 study was presented at the 51st Annual Conference of the International Society for Pediatric and Adolescent Diabetes and simultaneously published in Diabetologia.
Priority review is given to regulatory applications seeking approval
for therapies that have the potential to provide significant improvements in the treatment, diagnosis, or prevention of serious conditions.
safety and efficacy of Tzield in the PETITE-T1D population has not been approved by any regulatory authority.
PETITE-T1D (clinical study identifier:
NCT05757713) is an ongoing phase 4 single-arm,
non-randomized, open-label, multicentre study designed to assess the safety and pharmacokinetics of Tzield in children under eight years diagnosed with stage 2 T1D. Stage 2 T1D is defined by the presence of
two or more T1D-related autoantibodies and dysglycaemia.
The study has enrolled 23 participants.
The regimen consists of an intravenous infusion of Tzield once daily for 14 consecutive days. The study duration for each individual may last up to 26 months for follow up and monitoring.
Tzield (teplizumab-mzwv) is a CD3-directed monoclonal antibody. Tzield is the first and only disease-modifying
therapy in autoimmune T1D; it was first approved in the US in November 2022 to delay the onset of stage 3 T1D in adults and children eight years and older diagnosed with stage 2 T1D. Today, it is also approved in China, the UK, Canada, Israel, the
Kingdom of Saudi Arabia, the United Arab Emirates, and Kuwait for the same indication. In November 2025, the European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive recommendation for the same population
(Tzield will be known as Teizeild in the EU). Other regulatory reviews are ongoing.
About autoimmune T1D
T1D is a progressive autoimmune disease where the body's ability to regulate blood sugar levels is impacted due to the gradual destruction of
insulin-producing beta cells by one's own immune system. There are four stages to the progression of T1D:
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