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Sanofi Genzyme presents positive Phase 3 results for MS treatment

April 26, 2017

Sanofi Genzyme, the specialty care global business unit of Sanofi, announced today that new investigational data evaluating the effect of Aubagio® (teriflunomide) on cortical gray matter atrophy in patients with a first clinical episode suggestive of MS will be presented at the 69th American Academy of Neurology (AAN) Annual Meeting.

Data from the Phase III TOPIC study show Aubagio had a consistent and significant effect on reducing cortical gray matter atrophy across all time points evaluated over two years. Cortical gray matter is a part of the central nervous system that makes up the outer surface of brain tissue of the cerebral hemispheres. Gray matter is believed to be associated with cognitive function.

Compared to placebo, Aubagio reduced the median percentage of cortical gray matter atrophy:

Time Point

Aubagio 7 mg relative reduction
vs. placebo

Aubagio 14 mg relative reduction
vs. placebo

At month 6 58.2% (p=0.094) 119.2% (p=0.019)
At month 12 79.8% (p=0.054) 61.4% (p=0.036)
At month 18 69.5% (p=0.004) 66.8% (p=0.003)
At month 24 46.0% (p=0.009) 40.2% (p=0.042)

Accelerated cortical gray matter atrophy can be evident from the earliest stages of MS, which highlights the need for early intervention,” said Robert Zivadinov, M.D., Ph.D., Professor of Neurology at the University of Buffalo, Buffalo, NY. “Pathologic changes in gray matter are recognized as important contributors to disease worsening in MS, and strong predictors of potential future disability and impaired cognitive function. The data being presented at AAN demonstrating that Aubagio slowed the rate of cortical atrophy in patients showing early signs of MS are very promising.”

In the MS clinical studies of Aubagio, including TOPIC, the incidence of serious adverse events was similar among Aubagio and placebo-treated patients.

The TOPIC trial was designed to assess whether early initiation of Aubagio in patients with a first clinical episode 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 (p<0.05) to develop CDMS, the primary endpoint.

About Aubagio® (teriflunomide)
Aubagio is approved in more than 70 countries, with additional marketing applications under review by regulatory authorities globally. More than 70,0001 patients are currently being treated with Aubagio commercially worldwide.

Aubagio is an immunomodulator with anti-inflammatory properties. Although the exact mechanism of action for Aubagio is not fully understood, it may involve a reduction in the number of activated lymphocytes in the central nervous system (CNS). Aubagio is supported by one of the largest clinical programs of any MS therapy, with more than 5,000 trial participants in 36 countries.


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