Sanofi (SNY) has received US Food and Drug Administration accelerated approval for Tzield to delay the decline in endogenous insulin production in children aged 8 to 17 years recently diagnosed with stage 3 type 1 diabetes, the company said Friday.
The approval was supported by data from a phase 3 study in which Tzield significantly slowed the decline in mean C-peptide levels, compared with placebo, the company said.
Adverse events observed in the study were consistent with previous findings, according to the company.
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