The label of multiple sclerosis drug Tysabri, sold by Biogen Idec Inc. (BIIB) and Elan Corp. (ELN), has been changed to include the updated incidence of a rare brain infection.
A Biogen spokeswoman said the company worked with the Food and Drug Administration on the change, which includes a table that details the incidence of progressive multifocal leukoencephalopathy, or PML.
The included data shows the risk of getting the infection is 0.3 patients per 1,000 when using the drug for less than two years. That rate rises when using the drug for two to three years, to 1.5 cases, but notably drops to 0.9 cases for the period of three to four years. The data is current as of January and Biogen said the label will be updated as needed....Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1905