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Oral Therapy Teriflunomide (Aubagio™(*)) Significantly Reduces Relapses Leading to Hospitalization of Patients with Multiple Sclerosis
Date:10/19/2011

d rate of relapses leading to hospitalization was significantly reduced by 36% (p=0.015) with 7 mg and by 59% (p<0.0001) with 14 mg compared with placebo. The risk of hospitalization per relapse was also significantly reduced by 43% (p<0.001) for the 14 mg dose and numerically reduced by 6% (p=NS) for the 7 mg dose. These analyses also showed teriflunomide significantly reduced the annualized rate of emergency medical facility visits (a visit to a medical facility/hospital for emergency care not resulting in an admission) by 42% (p=0.004) for the 14 mg dose and numerically reduced by 31% (p=NS) for the 7 mg dose vs placebo.

"The additional data presented at ECTRIMS further supports the potential of teriflunomide as a new once a day oral therapy that can significantly decrease the number of relapses requiring hospitalizations for patients suffering from this complex and unpredictable disease and who need safer and more effective therapeutic options," said Dr. Elias Zerhouni, President, Global Research & Development, Sanofi.

Long-term data on safety and efficacy of teriflunomide were also presented at this congress. The results from the extension of the TEMSO study showed that both doses of teriflunomide were well tolerated six years after the initial randomization, with a consistent safety profile to the core two- year study. The beneficial effects of teriflunomide on clinical and MRI endpoints reported in TEMSO also continue to be sustained over five years after the initial randomization.

In addition to the TEMSO extension, the follow up to the Phase II long-term efficacy and safety study was presented. These new findings showed that teriflunomide was well tolerated up to nine years of continuous exposure, with a safety profile consistent with that reported during the 36 weeks of initial double-blind treatment. The reductions in disease activity observed with teriflunomide in the initial study were maintain
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