Argentina's National Administration of Drugs, Food and Medical Technology (ANMAT) has cleared Genzyme's once-daily, oral Aubagio 14mg to treat relapsing forms of multiple sclerosis (MS).
The approval of Aubagio was based on safety and efficacy data from the TEriflunomide Multiple Sclerosis Oral (TEMSO) trial.
The immunomodulator with anti-inflammatory properties is the first once-daily, oral Aubagio approved in Latin America, is also approved in both the US and Australia.
Genzyme MS Business SVP head Bill Sibold said, "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."
Aubagio is beleived to work by reducing the number of activated lymphocytes in the central nervous system.
