- Studies support potential of assay to stratify risk of PML in TYSABRI-treated patients -
Gothenburg, Sweden – October 16, 2010 – Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) today announced data further supporting the potential clinical utility of an investigational assay that detects anti-JC virus (JCV) antibodies in human plasma or serum. The detection of anti-JCV antibodies may provide a means to segment, or stratify, multiple sclerosis (MS) patients considering or receiving treatment with TYSABRI® (natalizumab) and assess their risk for developing progressive multifocal leukoencephalopathy (PML), a rare, but serious, brain infection. These data have been presented at the 26th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Gothenburg, Sweden.
This two-step, analytically-validated, enzyme-linked immunosorbant assay (ELISA) to detect anti-JCV antibodies is currently being evaluated in large-scale, prospective clinical studies (>10,000 patients) to determine the utility of the assay in stratifying the risk of PML in TYSABRI-treated patients. Infection with JCV is one of a number of factors required for the development of PML. Detection of anti-JCV antibodies may be a useful tool to identify prior or ongoing JCV infection, helping physicians better assess a patient’s potential risk for developing PML.
“When treating a debilitating, chronic disease such as MS, patient safety is of the utmost importance. At Biogen Idec, we are committed to improving the lives of people with MS. Understanding and mitigating potential treatment risk factors further support our commitment,” said Alfred Sandrock, M.D., Ph.D., Senior Vice President of Neurology Research and Development at Biogen Idec. "We are committed to better understanding PML and have embarked on a number of risk mitigation efforts. The anti-JCV antibody assay is one of our most advanced initiatives and has the potential to provide physicians a tool to help them assess patients’ risk for developing PML."
Gothenburg, Sweden – October 16, 2010 – Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) today announced data further supporting the potential clinical utility of an investigational assay that detects anti-JC virus (JCV) antibodies in human plasma or serum. The detection of anti-JCV antibodies may provide a means to segment, or stratify, multiple sclerosis (MS) patients considering or receiving treatment with TYSABRI® (natalizumab) and assess their risk for developing progressive multifocal leukoencephalopathy (PML), a rare, but serious, brain infection. These data have been presented at the 26th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Gothenburg, Sweden.
This two-step, analytically-validated, enzyme-linked immunosorbant assay (ELISA) to detect anti-JCV antibodies is currently being evaluated in large-scale, prospective clinical studies (>10,000 patients) to determine the utility of the assay in stratifying the risk of PML in TYSABRI-treated patients. Infection with JCV is one of a number of factors required for the development of PML. Detection of anti-JCV antibodies may be a useful tool to identify prior or ongoing JCV infection, helping physicians better assess a patient’s potential risk for developing PML.
“When treating a debilitating, chronic disease such as MS, patient safety is of the utmost importance. At Biogen Idec, we are committed to improving the lives of people with MS. Understanding and mitigating potential treatment risk factors further support our commitment,” said Alfred Sandrock, M.D., Ph.D., Senior Vice President of Neurology Research and Development at Biogen Idec. "We are committed to better understanding PML and have embarked on a number of risk mitigation efforts. The anti-JCV antibody assay is one of our most advanced initiatives and has the potential to provide physicians a tool to help them assess patients’ risk for developing PML."
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