Sanofi seeks expanded reach for diabetes drug  

PARIS – Sanofi has announced that the U.S. 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 company says 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 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,” said Christopher Corsico, global head of development at Sanofi. “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. 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.