Sanofi’s Tzield has been granted FDA priority review for use in children aged one and older who are diagnosed with stage 2 type 1 diabetes, with the agency expected to issue a decision by April 29 2026. The priority review accelerates the agency’s evaluation of the drug’s application, potentially expanding its approved age range beyond the current minimum of eight years.
Tzield, approved in November 2022 for patients eight years and older, is a monoclonal antibody that slows disease progression by protecting insulin‑secreting beta cells. The priority review is based on interim data from the PETITE‑T1D Phase 4 study, which enrolled 23 children under eight years old and demonstrated safety and pharmacokinetics consistent with the adult and older‑child populations.
The type 1 diabetes market is projected to reach $74 billion by 2034, and adding children as young as one year old significantly enlarges the addressable market. Tzield would become the first disease‑modifying therapy to delay progression to stage 3 in this age group, a milestone that could shift treatment paradigms and create a new revenue stream for Sanofi.
While insulin analogs remain the standard of care, Tzield is currently the only disease‑modifying therapy approved for type 1 diabetes. The approval could spur interest in other candidates and position Sanofi as a leader in early‑intervention therapies for autoimmune diabetes.
Christopher Corsico, Sanofi’s Global Head of Development, emphasized the importance of early intervention: “This priority review underscores the urgent need for innovative therapies like Tzield that can prevent the natural progression of type 1 diabetes by delaying the loss of endogenous insulin production, especially in young children where the autoimmune attack begins early in life.”
The approval would reinforce Sanofi’s diabetes portfolio, which already includes Lantus, Amaryl, Lyxumia, Zemiglo, and Soliqua. The company’s acquisition of Provention Bio in 2023 for $2.9 billion brought Tzield into its portfolio, and the expanded indication could accelerate revenue growth and strengthen Sanofi’s competitive position in a rapidly growing market.
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