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
"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.