French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) announced on Wednesday that the US Food and Drug Administration (FDA) has approved an expanded indication for Tzield (teplizumab-mzwv), broadening its use to children as young as one year old with stage 2 type 1 diabetes to delay progression to stage 3 disease.

The approval was granted under priority review and supported by one-year data from the PETITE-T1D phase 4 study evaluating safety and pharmacokinetics in young children.

The therapy is now the first disease-modifying treatment approved for patients aged one year and older diagnosed with stage 2 type 1 diabetes. This decision extends the prior indication, which covered patients aged eight years and above.

Tzield is also under FDA review for a potential indication to delay progression in patients aged eight years and older recently diagnosed with stage 3 type 1 diabetes. The drug has received breakthrough therapy and orphan drug designations in the United States.

Outside the US, Tzield (also known as Teizeild) is approved in multiple markets including the European Union, United Kingdom, China, Canada, Israel, Saudi Arabia, the United Arab Emirates, Kuwait, and Brazil for delaying progression to stage 3 disease in patients aged eight years and older.