Sunday, January 22, 2012

FDA: progressive multifocal leukoencephalopathy (PML) and Tysabri (natalizumab)

From the FDA:

FDA permits marketing of first test for risk of rare brain infection in some people treated with Tysabri
For Immediate Release: January 20, 2012

[snip]
"Today, the U.S. Food and Drug Administration allowed marketing of the first test to help determine the risk for a rare brain infection called progressive multifocal leukoencephalopathy (PML) in people using the drug Tysabri (natalizumab) to treat multiple sclerosis (MS) or Crohn’s disease (CD).

"The Stratify JCV Antibody ELISA test, when used with other clinical data from the patient, can help health care providers determine the risk for developing PML in MS and CD patients."
[snip]
Read the full press release

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