Tysabri labeling changes submitted to help stratify PML risk
Posted: Wed Dec 22, 2010 12:47 am
Biogen Idec and Elan Corporation, plc have announced that the companies have submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) and a Type II Variation to the European Medicines Agency (EMA) to request review and approval to update the respective Tysabri Prescribing Information and Summary of Product Characteristics.
The companies are proposing updated product labeling to include anti-JC Virus antibody status as one potential factor to help stratify the risk of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection, in the Tysabri-treated population.... Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1905