Drug news
Aubagio reduces significant relapses in patients with Multiple Sclerosis
A new Phase III trial shows that once-daily oral Aubagio (teriflunomide), from Sanofi-Aventis, significantly reduces annualised rates of relapses leading to hospitalization in patients with Multiple Sclerosis. The data also confirmed the safety profile and efficacy of Aubagio over a six-year period after the initial randomization. According to this post-hoc analyses of the TEMSO study, Aubagio-treated patients� annualized 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. according to the lead researcher professor paul oconnor director of the ms clinic at st. michaels hospital toronto canada 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. the data was presented at the congress of the european and american committee for treatment and research in multiple sclerosis. long-term data on safety and efficacy were also presented which showed that both doses of aubagio were well tolerated six years after the initial randomization with a consistent safety profile to the core two year study. the beneficial effects of aubagio on clinical and mri endpoints reported in temso also continue to be sustained over five years after the initial randomisation. aubagio was filed recently at the fda and genzyme sanofi plans to file at the eu in the first quarter of 2012.>