Results from the Phase III TEMSO Study of Teriflunomide
Teriflunomide Successfully Reduces Relapses and is Well Tolerated in Multiple Sclerosis Patients
– Phase III TEMSO study meets goals including delayed disability progression for teriflunomide 14mg –
Paris, France – October 15, 2010 – Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today the results from the two year phase III TEMSO study of teriflunomide, a novel oral disease modifier investigated for the treatment of relapsing multiple sclerosis (RMS). In this study, both doses of teriflunomide (7 and 14mg) significantly reduced annualized relapse rate (primary study endpoint) by 31% vs. placebo (p≤0.0005). The risk of disability progression (sustained for 12 weeks) was also significantly reduced by 30% for the 14mg dose (p=0.02) and numerically reduced by 24% for the 7mg dose (p=0.08). Both doses of teriflunomide were well tolerated with a similar number of patients reporting either treatmentemergent adverse events (TEAEs) including serious adverse events or TEAEs leading to treatment discontinuation in the treatment vs. placebo arms.
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