Genzyme, a Sanofi company (SNY), announced the European Medicines Agency, or EMA, has accepted the filing of the marketing authorization application, or MAA, for once-daily oral teriflunomide for the treatment of relapsing forms of multiple sclerosis, or MS.
The company noted that 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. These 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.
An application to market teriflunomide in the United States is under review by the U.S. Food & Drug Administration.
by RTT Staff Writer
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