CHMP recommends updating Tysabri labeling with anti-JC virus
Posted: Sun Apr 17, 2011 11:39 pm
Biogen Idec and Elan Corporation, plc announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for inclusion of an additional risk factor, anti-JC virus (JCV) antibody status, to the product label for Tysabri® (natalizumab) in the European uni0n (EU). The CHMP has also adopted a positive opinion for the five year renewal of the Marketing Authorisation for Tysabri.
The addition of anti-JCV antibody status as a risk factor allows for a three-factor approach to risk stratification. Prior immunosuppressant therapy and Tysabri treatment duration are established risk factors previously included in the product labeling. This provides an opportunity to identify patients at lower or higher risk for the development of progressive multifocal leukoencephalopathy (PML), an infrequent but serious brain infection.... Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1905