Sanofi’s Tzield approved in the US as the first disease-modifying therapy for patients recently diagnosed with stage 3 type 1 diabetes

Sanofi’s Tzield approved in the US as the first disease-modifying therapy for patients recently diagnosed with stage 3 type 1 diabetes

• Accelerated approval in children aged eight to 17 years old recently diagnosed with stage 3 T1D to delay the decline in endogenous insulin production
• Approval based on the PROTECT phase 3 study and additional data from the global clinical development program from over 900 patients who received Tzield

Paris, June 13, 2026. The US Food and Drug Administration (FDA) has granted accelerated approval to Tzield (teplizumab-mzwv) to delay the decline in endogenous (own) insulin production in children aged eight to 17 years recently diagnosed with stage 3 T1D. Tzield is not effective as a disease-modifying therapy in non-autoimmune dysglycemic conditions.

“We now have a novel therapy that targets the autoimmune and progressive nature of stage 3 type 1 diabetes,” said Aaron J. Kowalski, PhD, CEO of Breakthrough T1D. “Approximately 64,000 people are diagnosed with T1D every year. We are excited that the approval of Tzield in this indication provides a treatment option for certain patients diagnosed in stage 3 T1D, which is when many start experiencing common symptoms of the disease.”

The approval was supported by data from the PROTECT phase 3 study (clinical study identifier: NCT03875729), evaluating beta cell function as assessed by significantly slowing the decrease in mean C-peptide levels (area under the curve after a four-hour, mixed-meal tolerance test; difference in least-squares means 0.13 pmol/mL; 95% confidence interval: 0.09-0.17; p<0.001) at trial completion, compared to placebo, as well as data from the broader clinical development program that included over 900 patients who received Tzield. Adverse events observed in the PROTECT phase 3 study were consistent with previous studies.

The most common adverse reactions were lymphopenia, vomiting, rash, leukopenia, diarrhea, neutropenia, increased liver transaminase, and headache. Serious events such as cytokine release syndrome and life-threatening cases of viral reactivation have been reported with Tzield. Patients who are immunocompromised are at increased risk for viral reactivation.

This indication is granted under accelerated approval based on evidence of reduced C-peptide decline. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory study(ies).

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