More Safety, Efficacy Data for MS Drug Aubagio

More Safety, Efficacy Data for MS Drug Aubagio
More Safety, Efficacy Data for MS Drug Aubagio

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.

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.

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