November 22, 2012
Australian Therapeutic Goods Administration (TGA) has cleared Genzyme’s once daily oral Aubagio 14mg dose for the treatment of relapsing multiple sclerosis (MS).
Aubagio, which has anti-inflammatory properties, is expected to minimize activated lymphocyte count in the central nervous system.
Genzyme multiple sclerosis head Bill Sibold said with the TGA approval of Aubagio, healthcare professionals in Australia has a new once-daily option to treat people living with MS.
“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,” Sibold added.
The TEriflunomide Multiple Sclerosis Oral (TEMSO) trial data that revealed safety and efficacy profile of Aubagio was considered in the drug clearance.
MS Research Australia chairman professor Bill Carroll said, “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.”
The immunomodulator earlier received approval in the US, while marketing applications submitted to the European Medicines Agency and other regulatory bodies are still under review.
Source: PBR Regulatory Affairs
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