Genzyme, a Sanofi co. (SNY), announced that the Australian Therapeutic Goods Administration or TGA has approved Aubagio or teriflunomide 14 mg as a new once-daily, oral treatment indicated for patients with relapsing forms of multiple sclerosis or MS.
The company noted that the TGA's approval of Aubagio was based on safety and efficacy data from the TEMSO or TEriflunomide Multiple Sclerosis Oral trial.
The company said 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.
Aubagio is marketed in the U.S. and now Australia. Marketing applications for Aubagio are under review by the European Medicines Agency and other regulatory authorities, the compay said.
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