French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) announced on Monday that the US Food and Drug Administration (FDA) has accepted its supplemental biologic license application (sBLA) for Tzield (teplizumab-mzwv) under priority review.

The application seeks to expand Tzield's use to children aged one year and older with stage 2 type 1 diabetes to delay progression to stage 3.

The sBLA is supported by interim one-year data from the PETITE-T1D phase 4 study, which evaluates the safety and pharmacokinetics of Tzield in young children. Data were presented at the 51st Annual Conference of the International Society for Pediatric and Adolescent Diabetes and published in Diabetologia.

Tzield acts by protecting insulin-secreting beta cells, slowing disease progression.

Priority review is granted to therapies that could significantly improve treatment of serious conditions. The FDA target action date for the decision is 29 April 2026.

The safety and efficacy of Tzield in this population have not yet been approved by any regulatory authority.