Sanofi’s Teizeild (Teplizumab) Receives the CHMP’s Positive Opinion to Delay Progression of Type 1 Diabetes
Shots:
- The CHMP has recommended Teizeild 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 other regions
- Opinion was based on the P-II (TN-10) trial assessing Teizeild (QD, n=44) vs PBO (n=32) for 14 days in 76 T1D pts, where Teizeild delayed stage 3 onset by a median of ~2yrs. & kept 57% vs 28% of pts in stage 2
- Additionally, Sanofi is pausing its Teizeild application for recently diagnosed stage 3 T1D & evaluating next steps following CHMP’s positive opinion & discussions with the EMA
Ref: Sanofi | Image: Sanofi | Press Release
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