Genzyme, a Sanofi company, (EURONEXT: SAN and NYSE: SNY) announced today that the Australian Therapeutic Goods Administration (TGA) has approved AUBAGIO® (teriflunomide) 14 mg as a new once-daily, oral treatment indicated for patients with relapsing forms of multiple sclerosis (MS). The TGA approval will enable health professionals to prescribe AUBAGIO 14 mg in Australia, which is now the second country to gain marketing authorization for the treatment, following FDA approval in September.
"We are very pleased with the TGA approval of AUBAGIO that makes available a new option for healthcare professionals, and people living with MS in Australia who may benefit from this once-daily, oral treatment," said Bill Sibold, Head of Multiple Sclerosis, Genzyme. "The availability of AUBAGIO in the U.S. and subsequent registration in Australia not only demonstrates our continued progress, it also reflects our commitment to deliver differentiated treatments and provide access for patients globally."
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 program, 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 10 years.