Genzyme announced that the Food and Drug Administration (FDA) has approved the inclusion of clinical data from the TOWER and TOPIC studies of Aubagio (teriflunomide).

Aubagio, a pyrimidine synthesis inhibitor, was approved in September 2012 for patients with relapsing forms of multiple sclerosis (MS). This approval was based on data from the Phase 3 TEMSO study, which showed patients who received Aubagio 14mg had a statistically significant reduction in annualized relapse rate and relative risk of sustained disability progression.

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Results from the TOWER study also showed that patients with relapsing MS receiving Aubagio 14mg had a statistically significant reduction in annualized relapse rate and relative risk of sustained disability progression compared to placebo. Also, there was a significant reduction in annualized relapse rate in patients with Aubagio 7mg compared to placebo.


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Results from the TOPIC study showed a statistically significant greater proportion of patients that were free of relapse in the Aubagio 14mg and 7mg groups compared to placebo. The pooled safety analyses from all three Phase 3 trials were added to the label.

For more information call (800) 745-4447 or visit Aubagio.com.