Biogen Idec and Elan receive notification of PDUFA date extension

Biogen Idec and Elan Corporation plc announced that the US 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.

The FDA has indicated that the extension of the PDUFA date is needed to allow time for review of the changes being incorporated into the Risk Evaluation and Mitigation Strategies (REMS) program for TYSABRI, to be consistent with the anticipated Prescribing Information.