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Teriflunomide Successfully Reduces Relapses and is Well Tolerated in Multiple Sclerosis Patients
Date:10/15/2010

ultiple Sclerosis (ECTRIMS) congress, in Gothenburg, Sweden.

"Multiple sclerosis is a complex disease, and it often has an unpredictable and highly disabling disease course, therefore leading to important health care needs in this relatively young patient group ", said Dr. Paul O'Connor, Director of the MS Clinic at St Michael's Hospital, Toronto, Canada and principal investigator of the TEMSO study. "We were very satisfied to see how TEMSO demonstrated that teriflunomide successfully reduced relapse rate but also reduced the time to disability progression for the highest dose with a favorable safety profile for multiple sclerosis patients with relapses and emerges as a potential new first-line treatment option in this patient population."

Teriflunomide also significantly reduced the brain disease activity on a range of magnetic resonance imaging (MRI) measures including a significant reduction of the burden of disease (total lesion volume), by 39% (p=0.03) and 67% (p=0.0003) at the 7 and 14mg doses relative to placebo, respectively.

Teriflunomide was well tolerated with no major safety concerns. Adverse events occurring at a higher rate in the teriflunomide groups were diarrhea, nausea, alanine transferase increases that were mainly mild and asymptomatic with no dose effect and mild hair thinning and hair loss which rarely led to treatment discontinuation. No serious opportunistic infections occurred in patients treated with teriflunomide.

In addition to the TEMSO results, data on long-term safety of RMS patients, from eight years of follow-up of the open-label extension of a phase II study were also presented at the ECTRIMS congress. These data showed that teriflunomide was well tolerated during eight years of continuous use with a safety profile consistent with that reported during the first 36 double-blind phase weeks of the study.

About Teriflunomide

Teriflunomide is a new disease modifying drug being investigated
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SOURCE Sanofi-aventis
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