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Sanofi SA's Genzyme Once-daily, Oral AUBAGIO Approved In Argentina For Treatment Of Relapsing Multiple Sclerosis

Monday, 8 Apr 2013 09:00am EDT 

Genzyme, a Sanofi SA company announced Argentina`s National Administration of Drugs, Food and Medical Technology (ANMAT) has approved once-daily, oral AUBAGIO 14 mg as a new treatment indicated for patients with relapsing forms of multiple sclerosis (MS). The decision by ANMAT represents the first approval for once-daily, oral AUBAGIO in Latin America. AUBAGIO is also approved in both the United States and Australia, with additional marketing applications under review by regulatory authorities around the world. The ANMAT approval of AUBAGIO was based on safety and efficacy data from the TEMSO (TEriflunomide Multiple Sclerosis Oral) trial. The ongoing AUBAGIO clinical development program, involving more than 5,000 patients in 36 countries, is amongst the largest of any MS therapy. Some patients in extension trials have been treated for up to 10 years. AUBAGIO is an immunomodulator with anti-inflammatory properties. Although the exact mechanism of action for AUBAGIO is not fully understood, it may involve a reduction in the number of activated lymphocytes in the central nervous system (CNS). 

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23 Oct 2014