Aubagio (Genzyme/Sanofi)reports results of TOWER trial in Multiple Sclerosis - 01-Jun-2012

Top-line results are reported by Genzyme/Sanofi from the TOWER trial that assessed the efficacy and safety of once-daily, oral Aubagio (teriflunomide) in patients with relapsing forms of Multiple Sclerosis (MS). In the study, patients receiving teriflunomide 14 mg had a statistically significant reduction in annualized relapse rate and risk of sustained accumulation of disability. Analysis of the full TOWER data is ongoing and results will be presented at a forthcoming scientific meeting. -This double-blind, multi-center trial enrolled 1,169 patients and compared once-daily treatment with either 7 mg or 14 mg oral teriflunomide against placebo. Results from the primary and secondary endpoints for the proposed 14 mg commercial dose include the following: - A 36.3 percent reduction in annualized relapse rate, the primary endpoint of the trial, was observed in patients who received teriflunomide compared to placebo (p<0.0001) - A 31.5 percent reduction in the risk of 12-week sustained accumulation of disability, the main secondary endpoint, as measured by the Expanded Disability Status Scale (EDSS) was observed with teriflunomide compared to placebo (p=0.0442).Additionally a 22.3 percent reduction in annualized relapse rate was observed in patients treated with teriflunomide 7 mg compared to placebo (p=0.02); there was no statistically significant difference observed between teriflunomide 7 mg and placebo for the risk of 12-week sustained accumulation of disability.