FDA Approves Sanofi's Tzield (Teplizumab) for Children Down to Age 1 in Stage 2 Type 1 Diabetes — First Disease-Modifying Therapy for Pediatric T1D
Sanofi announced April 22 FDA approval of an expanded Tzield (teplizumab-mzwv) indication for stage 2 type 1 diabetes patients as young as 1 year old, down from the previous 8-and-up indication. The approval was supported by 1-year data from the PETITE-T1D Phase 4 study (n=23, mean age 4.8 years), showing 89.6% probability of remaining stage-3-progression-free at 1 year. Tzield delays progression from stage 2 to stage 3 T1D by an average of 2 years and is the first disease-modifying therapy for autoimmune T1D — relevant to the broader insulin/peptide endocrinology landscape.