PROVENTION BIO INC — Tzield FDA Review (BLA761183, SUPPL 10, 2026)
PROVENTION BIO INC · 2026 · FDA Review (openFDA)
Report summary
Tzield (teplizumab-mzwv) injection received FDA approval for two Type 1 Diabetes (T1D) indications: delaying Stage 3 T1D onset in patients aged 1+ with Stage 2 T1D, and delaying endogenous insulin decline in pediatric patients (8-17 years) recently diagnosed with Stage 3 T1D (accelerated approval, contingent on confirmatory trials). The approval is based on the PROTECT study, which demonstrated statistically significant C-peptide preservation in pediatric patients with newly diagnosed Stage 3 T1D. While key secondary endpoints like insulin use and HbA1c showed favorable trends, they did not reach statistical significance. Safety concerns include higher rates of cytokine release syndrome, rash, lymphopenia, and EBV reactivation (including severe and fatal cases), leading to a boxed warning for viral reactivation. Contraindications include immunocompromised patients and those with active viral infections. The report also details dosage, administration, pharmacokinetics, immunogenicity, and post-marketing requirements, including a confirmatory study for Stage 3 T1D.
Key findings — cited to the page
| Proportion of subjects experiencing CTCAE Grade 3 and above TEAEs (placebo) | 21.6 % | · p.97 |
| Proportion of subjects experiencing CTCAE Grade 3 and above TEAEs (teplizumab) | 56.7 % | · p.97 |
| Grade 1 CRS rate | 0.9 % | PROTECT Placebo · p.108 |
| Grade 3 CRS rate | 1.4 % | PROTECT trial · p.107 |
| Grade 1 CRS rate | 0.4 % | ISS Control · p.108 |
| Grade 1 CRS rate | 4.6 % | PROTECT Teplizumab · p.108 |
| Age for established safety and effectiveness to delay decline in endogenous insulin production in pediatric patients with Stage 3 T1D | less than 8 years years | · p.30 |
| Grade 3 CRS rate | 0.9 % | ISS (Integrated Summary of Safety) · p.107 |
| Serious infection rate (CTCAE Grade >=3) | 0.5 % | PROTECT study · p.106 |
| Serious infection rate (CTCAE Grade >=3) | 1.8 % | PROTECT study · p.106 |
| Grade 1 CRS rate | 1.6 % | ISS Teplizumab · p.108 |
| Grade 2 CRS rate | 2.6 % | ISS Teplizumab · p.108 |
Source: PROVENTION BIO INC ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Metabolic library →