Sanofi has announced that the US Food and Drug Administration (FDA) has accepted for priority review the supplemental biologics licence application for Tzield (teplizumab‑mzwv) to expand its use to children aged one year and older diagnosed with stage 2 type 1 diabetes.

• Regulatory Update: The FDA’s priority review is based on interim results from the ongoing PETITE‑T1D phase 4 study evaluating the safety and pharmacokinetics of Tzield in young children.
• Potential Impact: If approved, Tzield would be the first disease‑modifying therapy to delay the onset of stage 3 type 1 diabetes in this younger population.
• Target Date: The FDA’s target action date for the decision is 29 April 2026.

This summary is based on a press release issued by Sanofi.