Biogen Idec, Inc. (Massachusetts) and Elan Corporation PLC Receive Notification of PDUFA Date Extension
Published: Oct 20, 2011
WESTON, Mass. & DUBLIN--(BUSINESS WIRE)--Today Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced that the U.S. Food and Drug Administration (FDA) has extended the initial PDUFA date for its review of the supplemental Biologics License Application (sBLA) for TYSABRI® (natalizumab). The sBLA was submitted in December 2010 to update the Prescribing Information for TYSABRI to include anti-JC virus antibody status as a factor to help stratify the risk of progressive multifocal leukoencephalopathy (PML) in the TYSABRI-treated population. The 3 month extension is a standard extension period.