Shots:
- The US FDA has accepted sBLA & granted priority review to Tzield (teplizumab-mzwv) to delay of the onset of stage 3 T1D in pts (≥1yr.) diagnosed with stage 2 T1D (PDUFA: Apr 29, 2026)
- sBLA was supported by an interim 1yr. data from the ongoing P-IV (PETITE-T1D) trial assessing the safety & PK of Tzield (IV, QD for 14 consecutive days) in 23 young children (<8yrs.); data were presented at the International Society for Pediatric & Adolescent Diabetes & published in Diabetologia
- Tzield is a humanized monoclonal antibody targeting CD3, approved to delay the onset of stage 3 T1D by potentially modulating T-cell activity & preserving pancreatic beta-cell function
Ref: Sanofi | Image: Sanofi | Press Release
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