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news.Genzyme, a Sanofi company, announced promising data from a Phase III clinical trial, Tenere, that compared the efficacy, safety and tolerability of once-daily oral teriflunomide to interferon beta-1a, an approved injectable therapy for multiple sclerosis (RMS).
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Teriflunomide is an immunomodulatory, disease-modifying oral drug with anti-inflammatory properties, and is under investigation as a treatment for MS.
The Tenere trial, which was a two-year, randomized, rater-blinded comparator study comprising 324 patients, showed no statistical superiority between the Rebif and teriflunomide arms (7mg and 14mg) on risk of treatment failure, the primary composite endpoint of the study.
The data suggested that 48.6% of patients receiving 7mg of oral teriflunomide and 37.8% of patients receiving 14 mg of oral teriflunomide reached the primary endpoint, versus 42.3% of patients receiving interferon beta 1-a.
The teriflunomide 14 mg daily dose (0.259) and Rebif (0.216) were not distinguishable on the endpoint of estimated annual relapse rate.