Health Canada approves updates to Tysabri product monograph

A board to discuss the newly-released drug Tysabri, (formerly known as Antegren) as a treatment for Multiple Sclerosis

Health Canada approves updates to Tysabri product monograph

Postby MSUK » Wed May 23, 2012 7:43 am

Health Canada approves updates to Tysabri product monograph to include anti-JC virus antibody status

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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."... Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1905
MS-UK - http://www.ms-uk.org/
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Re: Health Canada approves updates to Tysabri product monogr

Postby andieincalgary » Wed May 23, 2012 8:04 am

so does this mean the jc virus test is available and approved in canada?

thx
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Re: Health Canada approves updates to Tysabri product monogr

Postby HarryZ » Thu May 24, 2012 6:08 am

And this label change is something new for docs involved in treating MS patients??!!

Dr. Bhan makes more than a few $$$ as a spokesperson for Biogen...not surprising!
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