Biogen Idec, Elan propose updated product labeling for TYSABRI to FDA and EMA

Dec 22 2010

Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) 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.

These filings are part of the companies' ongoing commitment to actively identify and address potential risk factors for PML in TYSABRI-treated patients.