Sanofi and its Genzyme subsidiary reported positive new data from the pivotal Phase III Temso trial evaluating oral teriflunomide therapy in patients with multiple sclerosis (MS). The results showed that once-daily oral teriflunomide therapy significantly reduced annualized rates of relapse leading to hospitalization, and confirmed the safety profile and efficacy of the drug over a six-year period.
Sanofi in addition confirmed that FDA accepted for review the teriflunomide NDA application, and projects filing for regulatory approval in Europe during the first quarter of 2012.
More specifically, the new Phase III study data showed that the annualized rate of relapse leading to hospitalization was reduced 36% among patients receiving the 7 mg dose of teriflunomide, and 59% among 14 mg-treated patients, compared with those on placebo. The low- and high-dose levels of teriflunomide therapy in addition reduced the annualized rate of emergency medical facility visits by 31%, and 42%, respectively.
Teriflunomide is an immunomodulatory disease-modifying oral drug in development for treating relapsing forms of MS. In addition to the Temso study, two Phase III trials, Tower and Tenere, are ongoing. Another Phase III study called Topic is separately under way to evaluate teriflunomide therapy in patients with early MS or clinical isolated syndrome, and the Phase III Teracles study is investigating the drug as an adjunct to interferon-beta therapy.