Sanofi and its subsidiary Genzyme has announced new data from the TEriflunomide multiple sclerosis oral (TEMSO) phase III trial showing once-daily oral teriflunomide significantly reduced annualized rates of relapses leading to hospitalization. New data also confirmed the safety profile and efficacy of teriflunomide over a six-year period after the initial randomization.
A total of fifteen presentations on teriflunomide are on the program for the fifth joint triennial congress of the European and American Committee for Treatment and Research in multiple sclerosis (ECTRIMS / ACTRIMS) in Amsterdam, The Netherlands.
The companies have also announced that the US Food and Drug Administration accepted for review Sanofi’s new drug application (NDA) for oral teriflunomide as a potential therapy for people with relapsing forms of multiple sclerosis (MS). Sanofi expects to file an application for regulatory approval with the European Medicines Agency (EMA) in the first quarter of 2012.
Professor Paul O’Connor, director of the MS Clinic at St Michael’s Hospital, Toronto, Canada, and principal investigator of the TEMSO study, The new results of the TEMSO study show that both 7mg and 14mg doses of teriflunomide could reduce the severity of relapses measured through annual rates of relapses leading to hospitalization as well as deliver encouraging long-term results on safety and efficacy.
Dr. Elias Zerhouni, President, Global Research & Development, Sanofi said, The additional data presented at ECTRIMS further supports the potential of teriflunomide as a new once a day oral therapy that can significantly decrease the number of relapses requiring hospitalizations for patients suffering from this complex and unpredictable disease and who need safer and more effective therapeutic options.
The results from the extension of the TEMSO study showed that both doses of teriflunomide were well tolerated six years after the initial randomization, with a consistent safety profile to the core two-year study. The beneficial effects of teriflunomide on clinical and MRI endpoints reported in TEMSO also continue to be sustained over five years after the initial randomization.
In addition to the TEMSO extension, the follow up to the phase II long-term efficacy and safety study was presented. These new findings showed that teriflunomide was well-tolerated up to nine years of continuous exposure, with a safety profile consistent with that reported during the 36 weeks of initial double-blind treatment. The reductions in disease activity observed with teriflunomide in the initial study were maintained for up to eight years of treatment.
TEMSO was a two-year randomized, double-blind, placebo-controlled multinational study that included 1,088 people with relapsing forms of MS from 126 centers in 21 countries. Trial participants were 18-55 years of age, with an Expanded Disability Status Scale (EDSS) of 5.5 or less, and had at least one relapse in the previous year or at least two relapses in the preceding two years. Trial participants were randomized to placebo or teriflunomide, 7mg or 14mg, once daily and followed for 108 weeks.