Paris: Sanofi has announced that 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, 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, the proportion of patients who remained in stage 2 T1D was twice as high in the Teizeild group as in the placebo group (57% vs 28%). The safety profile was consistent with previous studies of Teizeild, with the most frequently obser

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