Sanofi seeks to widen Tzield’s reach with US priority review

5 January 2026

French pharma Sanofi (Euronext: SAN) has won US priority review for Tzield (teplizumab-mzwv), aiming to extend use to children as young as one with stage 2 type 1 diabetes, well below the current lower age limit of eight.

The US Food and Drug administration (FDA) has accepted a supplemental biologics license application, with a target action date of April 29, 2026. The filing is supported by interim data from the PETITE-T1D Phase IV study in young children.

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