FDA updates Tysabri® label & approves PML test
Posted: Mon Jan 23, 2012 12:14 am
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