FDA Accepts Priority Review of Sanofi’s Tzield to Expand Treatment to Children Aged One and Older

FDA Accepts Priority Review of Sanofi’s Tzield to Expand Treatment to Children Aged One and Older

(IN BRIEF) Sanofi’s Tzield has been accepted for priority review by the U.S. Food and Drug Administration to expand its use to children aged one year and older with stage 2 type 1 diabetes. The submission is supported by interim data from the PETITE-T1D phase 4 study and aims to delay progression to stage 3 disease by protecting insulin-producing beta cells. If approved, Tzield would become the first disease-modifying therapy available for very young children with presymptomatic type 1 diabetes. The FDA’s target decision date is April 29, 2026.

(PRESS RELEASE) PARIS, 5-Jan-2026 — /EuropaWire/ — Sanofi announced that the U.S. Food and Drug Administration has accepted its supplemental biologics license application for Tzield for priority review, seeking to expand the therapy’s current age indication to include children as young as one year old diagnosed with stage 2 type 1 diabetes. If approved, the decision would make Tzield the first disease-modifying treatment shown to delay progression to stage 3 type 1 diabetes in this very young patient population.

The regulatory submission is supported by positive interim one-year data from the ongoing PETITE-T1D phase 4 study, which is evaluating the safety and pharmacokinetics of Tzield in young children. The FDA has set a target action date of April 29, 2026. Tzield is designed to slow the progression of type 1 diabetes by protecting insulin-producing beta cells in the pancreas, thereby delaying the onset of clinically manifest disease.

Christopher Corsico, Global Head of Development at Sanofi, said the priority review highlights the need for innovative therapies that address the underlying autoimmune mechanisms of type 1 diabetes at an early stage. He noted that autoimmune activity often begins very early in life and that delaying the loss of endogenous insulin production could be particularly meaningful for young children and their caregivers.

Interim findings from the PETITE-T1D study were recently presented at the 51st Annual Conference of the International Society for Pediatric and Adolescent Diabetes and published simultaneously in Diabetologia. Priority review status is granted to therapies that have the potential to offer significant improvements in the prevention or treatment of serious conditions. The safety and efficacy of Tzield in the PETITE-T1D population have not yet been approved by any regulatory authority.

PETITE-T1D (clinical study identifier: NCT05757713) is an ongoing, open-label, phase 4 study enrolling children under eight years of age with stage 2 type 1 diabetes, defined by the presence of multiple diabetes-related autoantibodies and abnormal blood glucose levels. Participants receive daily intravenous infusions of Tzield for 14 consecutive days and are followed for up to 26 months to monitor safety and pharmacokinetics.

Tzield is a CD3-directed monoclonal antibody and remains the first and only disease-modifying therapy approved to delay progression to stage 3 autoimmune type 1 diabetes. It was initially approved in the United States in 2022 for patients aged eight years and older and has since received approvals in multiple countries. In late 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive recommendation for the same age group, with additional regulatory reviews ongoing worldwide.

T1D is a progressive autoimmune disease where the body’s ability to regulate blood sugar levels is impacted due to the gradual destruction of insulin-producing beta cells by one’s own immune system. There are four stages to the progression of T1D:

• In stage 1, the autoimmune attack to the beta cells has started, and this can be detected by the presence of 2 or more T1D-related autoantibodies in the blood. During stage 1, blood sugar levels are in a normal range (normoglycaemia). At this stage, T1D is presymptomatic.
• In stage 2 (also presymptomatic), in addition to the presence of 2 or more T1D-related autoantibodies, blood sugar levels are now abnormal (dysglycaemia) due to the progressive loss of beta cells/beta-cell function.
• Stage 3 (also known as clinical stage) comes once a significant portion of the beta cells have been destroyed. At this point, rising blood sugar levels reach the point of clinical hyperglycaemia (which defines diabetes), and many people will start to experience the classic symptoms that come with the onset of stage 3 T1D: increased thirst, frequent urination, unexplained weight loss, blurred vision, and generalized fatigue. Management of stage 3 T1D requires daily and burdensome insulin replacement therapy.
• Stage 4 is defined as long-standing autoimmune T1D, often accompanied by evidence of chronic diabetic complications, where little to no beta cells remain (it’s been estimated that the beta-cell mass is reduced by up to 95%). At this point, the T1D-related autoantibodies might not be present anymore in the blood, as most beta cells have been rendered useless by the autoimmune attack.

About Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and creating compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.
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SOURCE: Sanofi