Sanofi's Diabetes Drug Tzield Granted US FDA Priority Review for Expanded Pediatric Use

05:54 AM EST, 01/05/2026 (MT Newswires) -- The US Food and Drug Administration granted priority review to Sanofi's (SAN.PA) supplemental biologic license application to expand the use of diabetes drug candidate Tzield in children as young as one year old and above. The French drugmaker announced on Monday that the potential approval would lower the age threshold for Tzield from eight years, allowing earlier treatment for patients with stage 2 type 1 diabetes and potentially delaying progression to stage 3 disease. The regulator set a target action date for its decision on April 29. If approved, Sanofi said the medication will be the "first disease-modifying therapy" for the age group. "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," Global Head of Development Christopher Corsico said. The application is backed by positive one-year interim data from the ongoing phase 4 Petite-T1D study. The single-arm, non-randomized, open-label, multi-center trial evaluated a 14-day daily infusion regimen in 23 children under eight years old to confirm the safety and pharmacokinetics of Tzield in the younger stage 2 type 1 diabetes population. Since its US debut for patients aged eight and older in November 2022, Tzield secured approvals in several global markets, including China, the UK and Saudi Arabia, for adults and children eight years and older diagnosed with stage 2 type 1 diabetes. Most recently, in November 2025, it received a positive recommendation for use in the European Union for the same population from the European Medicines Agency's Committee for Medicinal Products for Human Use, with further international regulatory reviews ongoing. Sanofi's shares were trading down nearly 1% late Monday morning.