FDA updates Tysabri® label & approves PML test : Tysabri (Antegren or Natalizumab) - This Is MS Multiple Sclerosis Community: Knowledge & Support

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FDA updates Tysabri® label & approves PML test

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squiffy2

Post subject: FDA updates Tysabri® label & approves PML test

Posted: Mon Jan 23, 2012 1:14 am

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Joined: Wed Oct 14, 2009 3:00 pm
Posts: 1711

Biogen Idec and Elan Corporation, plc announced that the U.S. Food and Drug Administration (FDA) has approved a product label change for Tysabri that will help enable individual benefit risk assessment for patients with multiple sclerosis (MS). The new label identifies anti-JCV antibody status as a risk factor for developing an infrequent 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 forms of MS.... Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1905

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Board index » Treatments » Tysabri (Antegren or Natalizumab)

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Topics		Author	Replies	Views	Last post
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	Health Canada approves updates to Tysabri product monograph	squiffy2	2	1017	Thu May 24, 2012 6:08 am HarryZ
	Biogen corrects the Tysabri label (in US only)	RuSmolikova	3	1169	Tue Jul 27, 2010 2:23 pm Drury
	MS drug Tysabri label updated to include PML incidence	squiffy2	0	884	Sun Apr 10, 2011 3:54 am squiffy2
	Tysabri Infusion updates...	msladyinca	7	5268	Fri Jan 16, 2009 1:44 pm harveythewonderhorse
	New MSRC Tysabri Diary Updates	squiffy2	0	896	Thu May 05, 2011 2:14 am squiffy2

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