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Teriflunomide reduces relapses in MS patients: Sanofi-aventis

Sanofi-aventis' Teriflunomide (7 and 14mg) Phase III Temso study for the treatment of relapsing multiple sclerosis (RMS) reduced annualised relapse rate (primary study endpoint) by 31% vs placebo.

The risk of disability progression (sustained for 12 weeks) was also reduced by 30% for the 14mg dose and numerically reduced by 24% for the 7mg dose, Sanofi-aventis said.

In the trial, both doses of Teriflunomide were well tolerated.

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

Sanofi-aventis Research & Development executive vice president Marc Cluzel said that they are very pleased with the successful results of the Temso study which are an important step forward in multiple sclerosis clinical research.

"These exciting results with Teriflunomide represent a new real hope to delivering an oral therapy to patients who live with this serious condition and are eager for new treatment options, and more convenient product forms in-line with our sanofi-aventis commitment to multiple sclerosis," Cluzel said.

Temso study principal investigator Paul O’Connor said that they are very satisfied to see how Temso demonstrated that Teriflunomide not only 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.