On January 12, 2026, the European Commission officially approved Sanofi’s Teizeild (teplizumab). This marks the first disease-modifying therapy authorized in the EU to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D.
Mechanism and Clinical Efficacy Teizeild is a CD3-directed monoclonal antibody that functions by addressing the underlying immune process that destroys insulin-producing beta cells. Based on the TN-10 Phase 2 study, the therapy demonstrated significant outcomes:
-
Delay of onset: Patients treated with Teizeild showed a median time of 48.4 months to a clinical diagnosis (Stage 3), compared to 24.4 months for the placebo group.
-
Function preservation: Approximately 57% of patients in the treatment group remained in Stage 2 by the end of the study, nearly double the rate of the placebo group (28%).
-
Safety profile: The most frequent adverse events were transient lymphopenia and skin rash, consistent with previous clinical observations.
The Significance of Early Intervention Type 1 diabetes progresses through four stages, with Stage 2 being a critical window where autoantibodies are present and blood sugar levels are abnormal, yet symptoms have not yet appeared. Delaying the transition to Stage 3 by an average of two years allows patients to live longer without the daily burden of insulin replacement therapy and reduces the immediate risk of chronic complications.
With this approval, the EU joins other major markets including the US, China, and the UK in adopting this innovative approach to altering the trajectory of autoimmune diseases.