Sanofi announced that the U.S. Food and Drug Administration has accepted its supplemental biologics license application for Tzield, granting the drug priority review status for use in children as young as one year old. The acceptance expands the current indication, which covers patients eight years and older, and could open a substantial new market for the disease‑modifying therapy.
The decision follows interim data from the PETITE‑T1D phase IV study, which enrolled 23 children under eight years old with stage 2 type‑1 diabetes. The study showed that a 14‑day intravenous infusion of Tzield was safe and produced the expected pharmacokinetic profile, with follow‑up extending to 26 months. The data support the safety and efficacy of the drug in a younger population that has historically been underserved.
By extending Tzield’s age range, Sanofi could capture a new patient cohort and strengthen its position in the growing pediatric diabetes market. Analysts estimate the expanded indication could generate up to $1 billion in annual revenue, and the priority review could shorten the FDA’s evaluation timeline to a target action date of April 29, 2026. The move also signals Sanofi’s commitment to disease‑modifying therapies and may improve its competitive standing against other immunology players.
Christopher Corsico, Sanofi’s Global Head of Development, said the priority review “underscores the urgency of providing innovative treatments that can delay insulin loss in young children, where the autoimmune attack begins early.” He added that the expanded indication could help families and clinicians manage type‑1 diabetes more effectively and reduce long‑term complications.
Following the announcement, Sanofi’s shares rose 2.8% in after‑hours trading, reflecting investor optimism about the potential market expansion and accelerated approval path. The market reaction highlights the importance of regulatory milestones in shaping investor sentiment for biopharmaceutical companies.
The FDA’s acceptance of the sBLA and the grant of priority review represent a significant regulatory win for Sanofi. If the agency follows its target action date, Tzield could become the first disease‑modifying therapy approved for children as young as one, positioning Sanofi at the forefront of pediatric diabetes treatment and potentially reshaping the therapeutic landscape for this patient population.
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