Pharmacy Daily | US oral MS approval

BIOGEN Idec has issued a statement confirming that its Tecfidera (dimethyl fumarate) treatment for Multiple Sclerosis is not registered for use in Australia. The update follows reports about the regulatory status of the drug which was approved by the US Food and Drug Administration last week as a first line oral treatment for people with relapsing MS. In the USA Biogen said it believes the drug will have a significant positive impact on the way people live with the chronic disease. The FDA approval follows clinical trials which showed Tecfidera reduced several important measures of disease activity including relapses and development of brain lesions, as well as slowing disability progression over time. Biogen said it had made a TGA submission in May 2012 seeking local registration, with the regulatory timeframe at the discretion of the regulator.

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