Press Release: Sanofi's Teizeild approved in the EU for patients with stage 2 type 1 diabetes

Core Viewpoint - Sanofi's Teizeild (teplizumab) has received approval from the European Commission to delay the onset of stage 3 type 1 diabetes (T1D) in patients aged eight years and older with stage 2 T1D, marking a significant advancement in the treatment of this autoimmune disease [1][2][8] Group 1: Approval and Study Results - Teizeild is the first disease-modifying therapy for T1D approved in the EU, based on the TN-10 phase 2 study, which showed a median delay of two years in the onset of stage 3 T1D compared to placebo [1][8] - In the TN-10 study, 57% of patients in the Teizeild group remained in stage 2 T1D at the end of the study, compared to 28% in the placebo group [2] - The median time to diagnosis of stage 3 T1D was 48.4 months for the Teizeild group versus 24.4 months for the placebo group, with a hazard ratio of 0.41 indicating a significant reduction in risk [6] Group 2: Safety and Efficacy - The safety profile of Teizeild was consistent with previous studies, with the most common adverse events being transient lymphopenia (75% of participants) and rash (36% of participants) [2][6] - The TN-10 study included 76 participants aged eight to 45, randomized to receive either Teizeild or placebo, focusing on the delay of stage 3 T1D [4][5] Group 3: Regulatory Status and Future Directions - Teizeild is already approved in multiple countries, including the US, UK, China, and Canada, for the same indication, with ongoing regulatory reviews in other regions [3][7] - Sanofi has decided not to pursue a second application for Teizeild in recently diagnosed stage 3 T1D at this time, with next steps under evaluation [3]