Shots:
- China’s NMPA has approved Tzield (teplizumab) to delay the onset of stage 3 type 1 diabetes (T1D) in adult & pediatric pts (≥8yrs.) with stage 2 T1D; regulatory review is ongoing in the EU & other regions
- Approval was based on the P-II (TN-10) trial assessing Tzield (QD for 14 days) vs PBO, which showed delayed median progression to stage 3 T1D to 48.4 vs 24.4mos.
- Tzield is a humanized monoclonal antibody targeting CD3, approved to delay the onset of T1D by potentially modulating T-cell activity & preserving pancreatic beta-cell function
Ref: Sanofi | Image: Sanofi | Press Release
Related News:- Sanofi’s Wayrilz (Rilzabrutinib) Receives the US FDA’s Approval for Immune Thrombocytopenia (ITP)
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