ARTICLE | Clinical News

Tysabri natalizumab regulatory update

January 23, 2012 8:00 AM UTC

FDA approved the Stratify JCV Antibody ELISA test to stratify the risk of developing progressive multifocal leukoencephalopathy (PML) in patients receiving autoimmune drug Tysabri natalizumab. The agency also approved a corresponding addition to Tysabri's label that identifies anti-JC virus antibody status as a risk factor for developing PML. FDA said the test is the first blood test approved for the indication. ...