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Sanofi SA's Genzyme Announces Results TOPIC Study into Aubagio


Wednesday, 24 Apr 2013 08:00pm EDT 

Sanofi SA's Genzyme announced positive top-line results from the TOPIC trial for AUBAGIO (teriflunomide). The trial was designed to assess whether early initiation of AUBAGIO (teriflunomide) in patients who experienced their first neurological symptoms consistent with Clinically Isolated Syndrome (CIS) can prevent or delay conversion to clinically definite multiple sclerosis (CDMS). In the TOPIC trial, patients receiving AUBAGIO 14 mg and 7 mg were significantly less likely to develop CDMS, defined as occurrence of a second clinical attack, the primary endpoint, as compared to placebo. Additional results, including key secondary and tertiary objectives, will be presented at a forthcoming scientific meeting. Primary results were: in patients who received AUBAGIO 14 mg, a 43% reduction in risk of conversion to CDMS was observed over the two-year study period, compared to placebo (p=0.0087); in patients who received AUBAGIO 7 mg, a 37% reduction in risk of conversion to CDMS was observed over the two-year study period, compared to placebo (p=0.0271). 

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