Sanofi Genzyme’s MS drug wins approval in Australia

Hannah Blake

pharmaphorum

After winning approval in the United States back in September, Sanofi Genzyme’s multiple sclerosis drug, aubagio, has won approval for use in Australia.

The Australian Therapeutic Goods Administration (TGA) has approved aubagio (teriflunomide) as a new once-daily, oral treatment for patients with relapsing forms of multiple sclerosis (MS). The TGA based its approval of aubagio on safety and efficacy data from the TEMSO (TEriflunomide Multiple Sclerosis Oral) trial.

“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. 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.”

Bill Sibold, Head of Multiple Sclerosis, Genzyme.

In another clinical trial, called TOWER (Teriflunomide Oral in people With relapsing multiplE scleRosis), aubagio was found to significantly reduce the yearly relapse rate and slow progression of disability in patients with relapsing forms of multiple sclerosis (MS) compared to placebo. This data was released by Sanofi’s Genzyme at the beginning of October 2012. Ongoing clinical development of aubagio, involving over 5000 patients in 36 countries, including Australia, is amongst the largest of any MS therapy.

“We welcome the advent of a new oral treatment option for MS patients in 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.”

Professor Bill Carroll, Chairman of MS Research Australia.

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