Genzyme gets Australian approval for MS therapy Aubagio

Sufferers of relapsing Multiple Sclerosis in Australia now have a new treatment available to them with the clearing last week by the Therapeutic Goods Administration of Genzyme’s Aubagio for sale in Australia.

Aubagio is an immunomodulator with anti-inflammatory properties, although the exact mechanism of action is not fully understood. It is believed to involve a reduction in the number of activated lymphocytes in the central nervous system. It is a once daily oral dose, simplifying treatment.

The approval came off the back off safety and efficacy data from the TEMSO (TEriflunomide Multiple Sclerosis Oral) trial, which found that the 14mg dose significantly reduced the annual relapse rate, as well as reducing disability progressions and improving several magnetic resonance imaging measures of disease activity.

It was approved for sale in the United States by the Food and Drug Administration in September of this year.

Results of the trial were published in 2011 in The New England Journal of Medicine

Professor Bill Carroll, Chairman of MS Research Australia, welcomed the announcement. “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.”

Severeal domestic life science companies are also exploring MS treatments, including Bionomics, which recently canned a collaboration with Merck Serono on its MS programme, and Innate Immunotherapeutics.