Genzyme Announces EMA Accepts Oral Teriflunomide Marketing Application for Treatment of Multiple Sclerosis

Genzyme, a Sanofi company

, announced today the European Medicines Agency (

) has accepted the filing of the marketing authorization application (

) for once-daily oral teriflunomide for the treatment of relapsing forms of multiple sclerosis (

). Acceptance of the MAA starts the EMA's review process. “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,” said Bill Sibold, Senior Vice President, Head of Multiple Sclerosis, Genzyme. “As an oral therapy with a promising clinical profile, teriflunomide is extremely well positioned to provide an alternative therapeutic option to patients who are currently taking injectable therapies. Those injectable therapies make up approximately 80 percent of the MS market today.”