Phase III Study Data Added to Aubagio’s Labeling

Latest News November 14, 2014

Genzyme, a Sanofi company, has announced that the United States Food and Drug Administration (FDA) approved adding the data from two Phase III studies to Aubagio®’s (teriflunomide) product label. These studies are the TOWER and TOPIC studies, which provide additional study results for Aubagio’s efficacy and safety. Aubagio was approved by the FDA in September 2012 and was the second of three (to date) oral medications approved as a disease-modifying therapy (DMT) for relapsing forms of MS.

The addition of this study data informs medical professionals that this medication has been shown to (1) reduce the relative risk of sustained disability progression (along with reducing the annual relapse rate), as found in the Tower study, and (2) prevent or delay a second clinical attack (relapse), as seen in the TOPIC study, in individuals who were not yet diagnosed but experienced their first neurological symptoms suggestive of MS. Individuals in this latter group, who have not yet been diagnosed with MS but have experienced symptoms, are referred to as having clinically isolated syndrome (CIS).

According to Genzyme’s press release, “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.

“The TOPIC study was designed to assess whether initiation of Aubagio in patients who experienced their first neurological symptoms suggestive of MS could prevent or delay a second clinical attack (i.e., relapse). In this study, the proportion of patients free of relapse was statistically significantly greater for Aubagio 14 mg and 7 mg, compared to placebo. Results of the TOPIC study were published in The Lancet Neurology in September 2014.”

For more information on Aubagio, please refer to:

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Written by Susan Wells Courtney
Reviewed by Jack Burks, MD, MSAA Chief Medical Officer

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