Australian TGA approves Genzyme’s AUBAGIO to treat relapsing forms of multiple sclerosis

Nov 21 2012

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.

"For some people living with MS, the additional burden of injectable therapies administered daily to weekly can sometimes be a struggle," said Associate Professor John King, Senior Neurologist, Royal Melbourne Hospital, who participated in the clinical trials for AUBAGIO. "It is exciting to see a new oral treatment that has been shown to both reduce relapses and slow the progression of disability. This is an encouraging development for the MS community."

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).

"We welcome the advent of a new oral treatment option for MS patients in Australia," said Professor Bill Carroll, Chairman of MS Research Australia. "It is important for people with MS and their clinicians to have access to a range of well-tolerated and convenient therapies that may reduce the impact of the disease on their lives and suit their lifestyle."

AUBAGIO is marketed in the U.S. and now Australia. Marketing applications for AUBAGIO are under review by the European Medicines Agency (EMA) and other regulatory authorities.