Results From Two Phase 3 Studies Added To U.S. Label Of Genzyme’s Aubagio
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme, a Sanofi company, announced today that the Food and Drug Administration (FDA) has approved the inclusion of efficacy and safety data from the TOWER and TOPIC studies of once-daily, oral Aubagio® (teriflunomide) in the product’s U.S. label.
In the TOWER study, patients with relapsing MS receiving Aubagio 14 mg had a statistically significant reduction in annualized relapse rate and relative risk of sustained disability progression compared to placebo. In addition, a significant reduction in annualized relapse rate was observed in patients treated with Aubagio 7 mg compared to placebo.
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In the TOWER study, patients with relapsing MS receiving Aubagio 14 mg had a statistically significant reduction in annualized relapse rate and relative risk of sustained disability progression compared to placebo. In addition, a significant reduction in annualized relapse rate was observed in patients treated with Aubagio 7 mg compared to placebo.
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