Sanofi's Tzield approved in US as first disease-modifying therapy for recent Stage 3 Type 1 Diabetes

The US Food and Drug Administration (FDA) has granted accelerated approval to Sanofi's Tzield (teplizumab-mzwv). The drug is indicated to delay the decline of endogenous insulin production in children aged eight to 17 years who have been recently diagnosed with Stage 3 Type 1 Diabetes (T1D).

The approval is supported by data from the PROTECT Phase 3 study, which demonstrated that Tzield significantly slowed the decrease in C-peptide levels compared to placebo. The study involved over 900 patients who received Tzield. This approval specifically targets patients with Stage 3 T1D, a stage characterized by significantly reduced self-insulin production.

Tzield is the first disease-modifying therapy for T1D that targets the autoimmune destruction of insulin-producing beta cells. While not a cure, the treatment aims to slow the progression of the disease and delay the onset of Stage 3 T1D, representing a significant advancement in disease management.

This approval is granted under accelerated approval, meaning continued approval may be contingent upon verification and description of clinical benefit in further studies. Sanofi has initiated the BETA-PRESERVE Phase 3 study to confirm the drug's clinical benefit. Common adverse reactions reported include lymphopenia, vomiting, and rash.