The U.S. Food & Drug Administration (FDA) has accepted Sanofi’s new drug application (NDA) for oral teriflunomide as a potential therapy for people with relapsing forms of multiple sclerosis

PARIS, October 20, 2011 /PRNewswire/ —

– New findings from the pivotal TEMSO Phase III study presented today at the joint ECTRIMS / ACTRIMS Congress –

– U.S. FDA Accepts New Drug Application for Teriflunomide for relapsing forms of MS –

Sanofi and its subsidiary Genzyme announced today new data from the pivotal TEriflunomide Multiple Sclerosis Oral (TEMSO) Phase III trial showing that 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, Netherlands.

The companies also announced today that the U.S. Food and Drug Administration has 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.

“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,“ said Professor Paul O’Connor, Director of the MS Clinic at St. Michael’s Hospital, Toronto, Canada, and principal investigator of the TEMSO study.

New post-hoc analyses showed that teriflunomide-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. 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. These analyses also showed teriflunomide significantly reduced the annualized rate of emergency medical facility visits (a visit to a medical facility/hospital for emergency care not resulting in an admission) by 42% (p=0.004) for the 14 mg dose and numerically reduced by 31% (p=NS) for the 7 mg dose vs placebo.

“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,” said Dr. Elias Zerhouni, President, Global Research & Development, Sanofi.