Sanofi’s Teizeild recommended for EU approval by the CHMP for patients with stage 2 type 1 diabetes.

Paris, November 14, 2025. The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Teizeild (teplizumab) to delay the onset of stage 3 T1D in adult and pediatric patients eight years of age and older with stage 2 T1D. The positive opinion is supported by positive data from the TN-10 phase 2 study (clinical study identifier: NCT01030861), which demonstrated that Teizeild significantly delayed the onset of stage 3 T1D by a median of approximately two years compared to placebo. At the end of the study...