Press Release: Sanofi's Teizeild recommended for EU approval by the CHMP for patients with stage 2 type 1 diabetes

Core Viewpoint - Sanofi's Teizeild (teplizumab) has received a positive recommendation from the CHMP for EU approval to delay the onset of stage 3 type 1 diabetes (T1D) in patients aged eight years and older with stage 2 T1D [1][2]. Summary by Sections Clinical Study Results - The TN-10 phase 2 study demonstrated that Teizeild significantly delayed the onset of stage 3 T1D by a median of approximately two years compared to placebo [2]. - At the end of the TN-10 study, 57% of patients in the Teizeild group remained in stage 2 T1D, compared to 28% in the placebo group [2]. - The safety profile of Teizeild was consistent with previous studies, with common adverse events including transient lymphopenia and rash [2]. Regulatory and Market Implications - If approved, Teizeild would be the first disease-modifying therapy for T1D in the EU [5]. - Sanofi is currently evaluating next steps regarding its application for recently diagnosed stage 3 T1D following the positive CHMP recommendation [3]. Background on T1D - T1D is a progressive autoimmune condition characterized by the destruction of insulin-producing beta cells, leading to dysregulation of blood sugar levels [4]. - The progression of T1D is categorized into four stages, with stage 2 indicating the presence of autoantibodies and abnormal blood sugar levels [6]. Study Design - The TN-10 study was a pivotal phase 2, randomized, placebo-controlled, double-blind trial involving 76 participants aged eight to 45, assessing the prevention or delay of stage 3 T1D [4][7].