Shots:
- The US FDA has approved Sanofi‘s Tzield (teplizumab-mzwv), under priority review, to delay of the onset of stage 3 T1D in pts (≥1yr.) diagnosed with stage 2 T1D
- Approval was supported by 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.)
- Tzield is a humanized monoclonal antibody targeting CD3, which is also being reviewed by the FDA to delay the progression of stage 3 T1D in pts (≥8yrs.) recently diagnosed with stage 3 T1D
Ref: Sanofi | Image: Sanofi | Press Release
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