New Phase III data for Aubagio (Sanofi) risk of MS relapse

Genzyme/Sanofi announced positive new data from the TOPIC study of its once-daily, oral Aubagio (teriflunomide). These new data, presented today at the 29th Congress of the European Committee for Research and Treatment in Multiple Sclerosis (ECTRIMS), include the following: � Aubagio 14 mg significantly reduced the risk of a new clinical relapse or MRI lesion over the two-year study period. There was a 35 percent reduction among patients who received Aubagio 14 mg compared to placebo (p=0.0003). � As measured by MRI over the two-year study period, there was a 5 per-cent increase in total lesion volume among patients treated with Aubagio 14 mg compared to a 28 per-cent increase among patients treated with placebo (p=0.0374). In addition, there was a 59 per-cent reduction in gadolinium-enhancing T1 lesions among patients treated with Aubagio 14 mg compared to placebo (p=0.0008). Similar results were observed for the 7 mg 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). Patients receiving Aubagio 14 mg and 7 mg in the TOPIC trial were significantly less likely than placebo to develop CDMS, the primary endpoint. Compared to placebo, Aubagio 14 mg reduced the risk of conversion to CDMS by 43 per-cent.