Natalizumab and Progressive Multifocal Leukoencephalopathy

Abstract

After learning of one confirmed and one suspected case of progressive multifocal leukoencephalopathy (PML) in patients treated with natalizumab, Biogen Idec and Elan quickly notified the Food and Drug Administration (FDA) and other regulatory authorities. We worked closely with the FDA to understand the significance of these findings and to determine the appropriate action. On February 28, we voluntarily suspended all dosing and marketing of natalizumab; swift and decisive action was guided by our commitment to patient safety. Immediate efforts also included a comprehensive review of all adverse events to search for unrecognized occurrences of PML. We identified as suspicious a report of malignant astrocytoma and requested a reevaluation. The case was subsequently confirmed to be PML.¹