Press Release: Sanofi's Teizeild recommended for EU approval by the CHMP for patients with stage 2 type 1 diabetes [Yahoo! Finance]
Sanofi - American Depositary Shares (SNY)
US:NYSE Investor Relations:
sanofi.com/en/investors
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Source: Yahoo! Finance
Recommendation based on the TN-10 study, demonstrating Teizeild's ability to delay the onset of stage 3 type 1 diabetes (T1D), compared to placebo, in adults and children with stage 2 T1D If approved, Teizeild would become the first disease-modifying T1D therapy in the EU Paris, November 14, 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, the proportion of patients who remained in stage 2 T1D was twice as high in the Teizeild group as in the placebo group (57%
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