Sanofi Says FDA to Review Expanded Age Range for Its T1D Drug

Sanofi announced that the U.S. Food and Drug Administration has accepted its supplemental biologics license application (sBLA) for priority review to broaden the approved age range of its type 1 diabetes therapy, Tzield (teplizumab‑mzwv), to include much younger patients. Currently indicated for people aged 8 years and older with stage 2 type 1 diabetes, Tzield could, if approved, be authorized for children as young as 1 year old who are diagnosed with stage 2 disease. The priority review designation was granted based on positive interim results from the ongoing PETITE‑T1D Phase 4 study, which examines safety and pharmacokinetics in young children. Sanofi said the treatment works by protecting insulin‑producing beta cells and delaying progression to clinical diabetes. The FDA’s target action date for deciding on the sBLA is April 29, 2026. If approved, this would make Tzield the first disease‑modifying therapy to potentially delay onset of stage 3 type 1 diabetes in children under age 8. Sanofi highlighted the significant unmet need for therapies that can alter the disease course early in life. #Sanofi #FDA #Tzield #Type1Diabetes #SlimScan #GrowthStocks #CANSLIM