Sanofi announced that the U.S. Food and Drug Administration has accepted its supplemental biologics license application for Tzield (teplizumab-mzwv) and granted it priority review, targeting approval to expand the therapy’s indication to children as young as one year old with stage 2 type 1 diabetes. Under the Prescription Drug User Fee Act, the FDA is expected to issue a decision within six months of the acceptance date, placing the target action date in mid-2026. If approved, Tzield would become the first immunotherapy indicated for the youngest cohort at risk of progressing to clinical disease, bolstering Sanofi’s position in the growing pediatric diabetes market, which sees approximately 18,000 new cases in children under five annually in the U.S.