TGA approves Genzyme's Aubagio
The Australian Therapeutic Goods Administration (TGA) has approved Genzyme's (Sanofi) Aubagio (teriflunomide) 14mg as a new once daily, oral treatment indicated for patients with relapsing forms of multiple sclerosis (MS). Australia is now the second country to gain marketing authorisation for the treatment, following FDA approval in September 2012.
The TGA's approval of Aubagio was based on safety and efficacy data from the TEMSO (TEriflunomide Multiple Sclerosis Oral) trial. The ongoing Aubagio clinical development programme, involving more than 5,000 patients in 36 countries including Australia, is amongst the largest of any MS therapy. Some patients in extension trials have been treated for up to ten years. The product 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.