FDA Approves Tzield for Children With New Stage 3 Type 1 Diabetes

WEDNESDAY, July 1, 2026 (HealthDay News) — The U.S. Food and Drug Administration has granted accelerated approval to Tzield (teplizumab-mzwv) to delay the decline in endogenous insulin production in children aged 8 to 17 years recently diagnosed with stage 3 type 1 diabetes.

The approval was based on results of the PROTECT phase 3 study which randomly assigned 328 children and adolescents (aged 8 to 17 years) diagnosed with clinical stage 3 type 1 diabetes in the preceding six weeks to either Tzield or placebo. Results showed a significant slowing of the decrease in mean C-peptide levels compared to placebo.

Adverse events observed in the PROTECT phase 3 study were consistent with previous studies and most commonly included lymphopenia, vomiting, rash, leukopenia, diarrhea, neutropenia, increased liver transaminase, and headache. Serious events (e.g., cytokine release syndrome and life-threatening cases of viral reactivation) have been reported with Tzield, with viral reactivation risk increased in immunocompromised patients. Tzield is not effective as a disease-modifying therapy in non-autoimmune dysglycemic conditions.

“We welcome this accelerated approval by the FDA, which recognizes the potential of Tzield to delay the progression of recently diagnosed stage 3 type 1 diabetes in children aged 8 to 17 years,” Christopher Corsico, from Sanofi, said in a statement. “Tzield will now offer a new pathway in the treatment paradigm of stage 3 type 1 diabetes, one that we hope will further enable health care providers in the U.S. to take a more proactive approach to disrupt the underlying autoimmune attack against insulin-producing beta cells.”

Approval of Tzield was granted to Sanofi.

More Information