Globenewswire·2026-01-12 06:00Core 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 Significance - Teizeild is the first disease-modifying therapy for T1D approved in the EU, representing a major milestone in treatment options for patients [1][8]. - The approval is based on the TN-10 phase 2 study, which showed that Teizeild delayed the onset of stage 3 T1D by a median of two years compared to placebo [1][8]. Group 2: Study Results - In the TN-10 phase 2 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 3: Safety Profile - 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]. Group 4: Regulatory Status - Teizeild is also approved in multiple countries including the US, UK, China, Canada, and several Middle Eastern nations 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]. Group 5: About Teizeild - Teizeild is a CD3-directed monoclonal antibody and is the only disease-modifying therapy for autoimmune T1D, having been approved in the US in November 2022 [7]. - The therapy aims to prevent the natural progression of T1D by protecting beta-cell function [2][8]. Group 6: Understanding T1D - Type 1 diabetes is a progressive autoimmune disease characterized by the destruction of insulin-producing beta cells, leading to impaired blood sugar regulation [9]. - The disease progresses through four stages, with stage 2 being presymptomatic but marked by abnormal blood sugar levels [12].