15 Dec 2008 15:02
Elan Corporation, plc
15 December 2008
On December 11, 2008, relevant regulatory agencies were notified of a confirmed case of progressive multifocal leukoencephalopathy (PML) in a multiple sclerosis (MS) patient treated with TYSABRI in the commercial setting in the European Union as part of TYGRIS: TYSABRI® Global Observational Program in Safety - ROW. Additional information about this case is set forth below.
The diagnosis was made based upon the detection of JC Virus (JCV) DNA in the cerebrospinal fluid (CSF) in the setting of clinical signs, symptoms and magnetic resonance imaging (MRI) findings consistent with the diagnosis of PML.
Background:
Patient has a history of MS and prior disease modifying therapies, including beta-interferons; Patient received approximately 26 months of TYSABRI monotherapy; Clinical vigilance led to early identification of signs and symptoms of possible PML and clinical evaluation which included MRI scanning and CSF testing; Patient is under the care of patient's treating physician.Copyright Business Wire 2008