Tzield(teplizumab-mzwv)

Tzield (teplizumab-mzwv) received initial U.S. approval in 2022. It is administered over 14 consecutive days for Stage 2 Type 1 Diabetes (T1D), with infusion durations of 30 minutes for adults and pediatric patients aged 8 years and older, and 2 hours for pediatric patients aged 1 to less than 8 years. For Stage 3 T1D, Tzield is administered over 12 consecutive days per course, with two total treatment courses, the second occurring 6 months after the first.

In efficacy studies, Tzield demonstrated a difference from placebo in LSMean change from baseline in C-peptide AUC (log transformed) of 0.13 pmol/mL (p-value <10-5). The LSMean difference in average insulin use (teplizumab - placebo) was -0.131 units/kg/day (p-value 0.085). The LSMean difference in change from baseline A1C (teplizumab - placebo) was -0.09% (p-value 0.606), and the LSMean difference in Time in Range (teplizumab - placebo) was 4.71%. The event rate of Level 2 hypoglycemia was 4.24 events/patient-year.

Safety considerations for Tzield include specific thresholds for use: lymphocyte count less than 1,000 lymphocytes/mcL, hemoglobin less than 10 g/dL, platelet count less than 150,000 platelets/mcL, absolute neutrophil count less than 1,500 neutrophils/mcL, ALT or AST greater than 2 times ULN, or bilirubin greater than 1.5 times ULN. Discontinuation criteria include prolonged severe lymphopenia (<500 cells per mcL lasting 1 week or longer) or elevated ALT or AST more than 5 times ULN or bilirubin more than 3 times ULN. A Postmarketing Requirement Final Report Submission Date is set for December 2029.