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.
2Hans-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.
SOURCE Biogen Idec