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Sanofi SA's Gezyme Announces Positive TOPIC Study of Once-daily Oral Aubagio


Thursday, 3 Oct 2013 04:45am EDT 

Sanofi SA announced that its Genzyme announced positive new data from the TOPIC study of its once-daily, oral Aubagio (teriflunomide). According to the study results, Aubagio 14 milligram significantly reduced the risk of a new clinical relapse or MRI lesion over the two-year study period. As measured by MRI over the two-year study period, there was a 5% increase in total lesion volume among patients treated with Aubagio 14 milligram compared to a 28% increase among patients treated with placebo. In addition, there was a 59% reduction in gadolinium-enhancing T1 lesions among patients treated with Aubagio 14 milligram compared to placebo. Similar results were observed for the 7 milligram dose, though the effects did not achieve statistical significance on some endpoints. The TOPIC trial was designed to assess whether early initiation of Aubagio in patients who experienced their first neurological symptoms suggestive of MS could prevent or delay a second clinical attack, i.e., conversion to clinically definite multiple sclerosis (CDMS). As previously announced, patients receiving Aubagio 14 milligram and 7 milligram in the TOPIC trial were significantly less likely than placebo to develop CDMS, the primary endpoint. Compared to placebo, Aubagio 14 milligram reduced the risk of conversion to CDMS by 43%. 

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