Health Canada approves Biogen Tysabri label change

Health Canada has approved a change
to the TYSABRI Product Monograph to assist physicians and patients with
multiple sclerosis (MS) make better-informed decisions about treatment with
TYSABRI – for patients with relapsing-remitting form of MS. 

The new label identifies anti-JC
virus (JCV) antibody status as a risk for developing an uncommon, but serious,
brain infection known as progressive multifocal leukoencephalopathy
(PML). 

The new label
states that:

·        
Anti-JCV antibody negative status indicates that
exposure to the JC virus has not been detected;

·        
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 (IS) therapy and have received treatment
with TYSABRI for more than two years have the highest risk of developing PML.

For more information, please view
the news release at:
http://www.newswire.ca/en/story/979137/health-canada-approves-updates-to-tysabri-natalizumab-product-monograph-to-include-anti-jc-virus-antibody-status