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

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. Food and Drug Administration and the European Commission approvals of anti-JCV antibody status as an additional factor to aid in stratifying patients at risk for developing PML. Through the third quarter of 2011, globally there have been approximately 59,000 anti-JCV antibody tests administered commercially and through clinical trials.

About TYSABRI
TYSABRI is approved in more than 65 countries. TYSABRI is approved in Canada as monotherapy treatment of patients with the relapsing-remitting form of MS, and is generally recommended in MS patients who have had an inadequate response to, or are unable to tolerate, other therapies for MS.

TYSABRI has advanced the treatment of MS patients with its established efficacy. Data from the Phase 3 AFFIRM trial, which was published in the New England Journal of Medicine, showed that after two years, TYSABRI treatment led to a 68 per cent relative reduction (p<0.001) in the annualized relapse rate when compared with placebo and reduced the relative risk of disability progression by 42 to 54 per cent (p<0.001).

TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain, which usually leads to death or severe disability. Infection by the JC virus (JCV) is required for the development of PML and patients who are anti-JCV antibody positive have a higher risk of developing PML. Factors that increase the risk of PML are presence of anti-JCV antibodies, prior immunosuppressant use, and longer TYSABRI treatment duration. Patients who have all three risk factors have the highest risk of developing PML. Other serious adverse events that have occurred in TYSABRI-treated patients include hypersensitivity reactions (e.g., anaphylaxis) and infections, including opportunistic and other atypical infections. Clinically significant liver injury has also been reported in the post-marketing setting. A list of adverse events can be found in the  TYSABRI product monograph.

TYSABRI is marketed and distributed in Canada by Biogen Idec Canada Inc.

Multiple Sclerosis in Canada
Canada is known for having one of the highest prevalence of MS in the world.¹  Currently, more than two million people are estimated to suffer with MS worldwide,² including between 55,000 and 75,000 Canadians.  The overall weighted estimate of MS rates in Canada is 240 per 100,000 people³ causing three or more people per day to be diagnosed with MS.⁴

About Biogen Idec Canada Inc.
Biogen Idec Canada Inc. is the Canadian affiliate of Biogen Idec.  Through cutting-edge science and medicine, Biogen Idec discovers, develops, manufactures and markets therapies for diseases with a focus on neurology, immunology and hemophilia.  Founded in 1978, with a presence in Canada since 1998, it is the world's oldest independent biotechnology company. Patients worldwide benefit from its leading multiple sclerosis therapies and the company generates more than $5 billion in annual revenues.

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¹ "MS Experts estimate number of Canadians with MS is 55,000 to 75,000." Multiple Sclerosis Society of Canada, accessed January 6, 2012, http://mssociety.ca/en/research/medmmo-prev-may_02.htm.

² Hans-Peter Hartung, "Impact of mobility impairment in multiple sclerosis 1 - Healthcare professionals perspectives."  European Neurological Review: 110.

³ "MS Experts estimate number of Canadians with MS is 55,000 to 75,000." Multiple Sclerosis Society of Canada, accessed January 6, 2012, http://mssociety.ca/en/research/medmmo-prev-may_02.htm.

⁴ "About MS." Multiple Sclerosis Society of Canada, accessed January 6, 2012, http://mssociety.ca/en/information/default.htm.

 

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