WESTON (dpa-AFX) - Biogen Idec (BIIB) announced that Health Canada has approved a product monograph change for TYSABRI that will help enable individual benefit risk assessment for patients with multiple sclerosis (MS). The new label identifies anti-JC virus or JCV antibody status as a risk factor for developing an uncommon, but serious, brain infection known as progressive multifocal leukoencephalopathy or PML.
Infection with the JC virus or JCV is required for the development of PML. The new label states that anti-JCV antibody negative status indicates that exposure to the JC virus has not been detected, while patients who are anti-JCV antibody positive have a higher risk of developing PML. Patients who are anti-JCV antibody positive, have received prior immunosuppressant or IS therapy and have received treatment with TYSABRI for more than two years have the highest risk of developing PML.
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