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Investigational Oral Multiple Sclerosis Therapy Teriflunomide (Aubagio™(*)) Significantly Reduced Relapse Rate, Disability Progression and Disease Activity
Date:10/5/2011

o research, innovation and the Multiple Sclerosis community, we look forward to providing therapeutic options for patients across the Multiple Sclerosis spectrum."

Teriflunomide has been filed with the FDA in August of 2011 and the EMA filing is expected in the first quarter of 2012.  The results from the TEMSO study are and will be included in each regulatory submission.

TEMSO findings showed that, compared to placebo, teriflunomide once daily:

  • Significantly reduced the risk of annual relapses, the primary endpoint, by 31% (both p<0.001) for 7mg and 14mg doses.

  • Significantly increased the time to first relapse, and allowed significantly more trial participants to remain free of relapses during the two years of the study: 53.7% (7mg, p=0.01 vs. placebo), 56.5% (14mg, p=0.003 vs. placebo) and 45.6% (placebo).

  • The risk of 12-week confirmed disability progression, the key secondary endpoint, was significantly reduced by 30% (p=0.03) for the 14mg dose and numerically reduced by 24% (p=0.08) for the 7mg dose.

  • Improved several standard magnetic resonance imaging (MRI) measures of disease activity as compared to placebo including new or worsening brain lesions with an apparent dose dependent effect in favor of the 14mg dose:
    • Reduced burden of disease (by 39.4% [p=0.03] and 67.4% [p<0.001] for 7mg and 14mg, respectively);
    • Reduced gadolinium-enhancing T1 lesions (relative risk reduction of 57% and 80%, p<0.001 for both doses);
    • Reduced unique active lesions per scan (relative risk reduction of 48% and 69%, p<0.001 for both doses).

Similar adverse events, serious adverse events, and adverse events leading to treatment discontinuation were observed with teriflu
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SOURCE Sanofi; Genzyme
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