Genzyme, a Sanofi company, announced today 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).
Studied in one of the largest clinical trial programs of any MS treatment, AUBAGIO has had consistent effects across all the important measures of MS disease activity including slowing the progression of disability, reducing the number of brain lesions as detected by MRI and reducing relapses. The clinical data supporting AUBAGIO confirm its importance as a new treatment option for MS patients, said Dr. Jorge Correale, Head of Neuroimmunology and Demyelinating Diseases, Raul Carrea Institute for Neurological Research FLENI, Argentina.
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 approval in Argentina of once-daily, oral AUBAGIO represents another important advancement for the Genzyme MS Franchise,” said Bill Sibold, SVP, Head of MS Business, Genzyme. “Genzyme is committed to becoming leaders in MS and developing differentiated treatments that can address the diverse needs of the MS community. Now approved on three continents, AUBAGIO’s established efficacy and convenient dosing can provide many patients with an attractive alternative to frequent and potentially burdensome injections.”
The ANMAT approval of AUBAGIO was based on safety and efficacy data from the TEMSO ( TE riflunomide M ultiple S clerosis O ral) 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, in its clinical studies, has shown favorable efficacy and a well-characterized safety profile. With its once-daily oral administration and tolerability, AUBAGIO should contribute positively to the care of patients with Multiple Sclerosis,” said Dr. Edgardo Cristiano, Head of the Neurology Department of the Hospital Italiano de Buenos Aires, Argentina.