Genzyme announced that data from the Phase 3 TEMSO study demonstrate that Aubagio (teriflunomide) significantly slowed brain volume loss, or atrophy, vs. placebo over two years in people with relapsing multiple sclerosis (RMS). These data will be presented at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Barcelona, Spain on October 10, 2015.
Magnetic resonance imaging (MRI) data from TEMSO were analyzed utilizing SIENA (structural image evaluation using normalization of atrophy), an alternative methodology than originally used. Change in brain volume from baseline was assessed in patients treated with Aubagio 14mg or 7mg vs. placebo.
By month 12, median percent reduction in brain volume from baseline was 0.39, 0.40, and 0.61 for Aubagio 14mg, 7mg, and placebo, respectively. This change was lower for both Aubagio groups vs. placebo: 14mg by 36.9%, P=0.0001; 7mg by 34.4%, P=0.0011. The significant difference in reduction of brain atrophy for Aubagio vs. placebo was maintained at month 24. Median percent reduction in brain volume from baseline was 0.90, 0.94, and 1.29 for Aubagio 14mg, 7mg, and placebo, respectively. This change was lower for both Aubagio groups vs. placebo: 14mg by 30.6%, P=0.0001; 7mg by 27.6%, P=0.0019.
Aubagio is an immunomodulator with anti-inflammatory properties indicated for the treatment of patients with relapsing forms of multiple sclerosis.
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