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news.The European Medicines Agency (EMA) has accepted the Genzyme's filing of the MAA for once-daily oral teriflunomide for the treatment of relapsing forms of multiple sclerosis (MS).
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Teriflunomide is an immunomodulatory, disease-modifying oral drug with anti-inflammatory properties, and is under investigation for the treatment of MS.
The purpose of the MAA is to secure approval to market and allow prescription of teriflunomide in the European Union based on data from two completed pivotal Phase III trials, TEMSO and TENERE.
The trials represent two of five efficacy studies of teriflunomide in MS that are completed or underway, making the clinical program one of the largest and broadest of any MS therapy in development.
Genzyme Multiple Sclerosis head senior vice president Bill Sibold said the filing represents another important milestone for teriflunomide.