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EC includes anti-JC virus antibody status as PML risk factor in Tysabri labeling



Biogen Idec Inc. and Elan Corporation, plc Wednesday said the European Commission has approved the inclusion of anti-JC virus antibody status as an additional factor to aid in stratifying patients at risk for developing progressive multifocal leukoencephalopathy in the Summary of Product Characteristics for Tysabri in the European Union.

In addition, as part of a standard review process, the European Commission concluded the quality, safety and efficacy of Tysabri continue to be adequately demonstrated and renewed the EU five-year Marketing Authorisation.... Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1905

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