Sanofi-Aventis' oral drug teriflunomide reduces relapses in multiple sclerosis patients by 31%

French drug major Sanofi-Aventis (Euronext: SAN) announced positive 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), which met its goals, including delayed disability progression. The data were presented during the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) congress, in Gothenburg, Sweden last Friday.

The French company’s product would be a relative late comer in the race to bring oral MS treatments to the market, with Novartis heading the pack with its Gilenya (fingolimod) - which last month gained US regulatory approval, and Merck KGaA’s cladribine, which is having limited success in gaining approval from the regulatory authorities in leading markets (The Pharma Letters passim).

In this study, both doses of teriflunomide (7mg and 14mg) significantly reduced annualized relapse rate (primary study endpoint) by 31% versus placebo (p=less than or equal to 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 treatment-emergent adverse events (TEAEs) including serious adverse events or TEAEs leading to treatment discontinuation in the treatment vs. placebo arms.