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Sanofi and Genzyme’s MS drug accepted for European review
Sanofi and Genzyme's new oral teriflunomide treatment for multiple sclerosis (MS) has been accepted for review by the European Medicines Agency (EMA).
Following the filing of the marketing authorisation application for the once-daily therapy option, the European regulator will begin a review process that will assess the efficacy of the drug for the treatment of relapsing forms of MS.
The application is supported by positive data from two pivotal phase III clinical trials, which come as part of a planned series of five studies.
Genzyme's drug is also currently under review in the US and could prove to be a useful alternative to the injectable therapies that currently dominate the market.
Bill Sibold, senior vice-president and head of multiple sclerosis at Genzyme, said: "The filing represents another important milestone for teriflunomide and brings us one step closer to offering a new treatment option to patients with relapsing MS."
Genzyme was acquired by Sanofi last year, a deal which helped the company to achieve year-on-year sales growth in 2011.
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