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Health Canada Approves Updates to TYSABRI? (natalizumab) Product Monograph to Include Anti-JC Virus Antibody Status

Wednesday, May 23, 2012 9:17 AM

TORONTO, May 23, 2012 /CNW/ - Today Biogen Idec 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 (JCV) antibody status as a risk factor for developing an uncommon, but serious, brain infection known as progressive multifocal leukoencephalopathy (PML). This marks the third risk factor identified to help physicians and people with MS have more confidence in their treatment decisions when considering TYSABRI, a highly effective treatment for relapsing remitting forms of MS.

"This label change marks an important advance in assisting people with MS and their physicians to make better informed decisions concerning the challenges of balancing effectiveness with safety," said Dr. Virender Bhan, Director, Dalhousie MS Research Unit, Halifax, Nova Scotia. "TYSABRI is an important treatment option for appropriate patients so the ability to confidently address PML risk stratification may allow for earlier treatment to reduce the frequency of clinical exacerbations and delay the progression of physical disability."

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

"TYSABRI has benefited thousands of patients worldwide who are living with multiple sclerosis, an often devastating disease affecting people in the prime of their lives," said Paul Petrelli, General Manager, Biogen Idec Canada Inc. "Biogen Idec's use of novel research and scientific expertise has allowed us to gain a better understanding of the benefit-risk profile for TYSABRI. Our development of a risk stratification algorithm and subsequent efforts to support the commercial availability of anti-JCV antibody testing reflect our commitment to providing patients and their physicians with additional guidance to help them make more personalized treatment decisions."

Biogen Idec's quantitative risk stratification algorithm, which was presented at a number of major international medical meetings, shows that patients who were anti-JCV antibody positive were at an increased risk for developing PML with varying degrees of risk depending on prior IS use and TYSABRI treatment duration. Irrespective of MS treatment, approximately 55 per cent of MS patients are anti-JCV positive.

The Canadian label update follows the U.S.


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