Tysabri Could Return In Fall; Marketing Suspended By Biogen Idec And Elan
This article was originally published in The Pink Sheet Daily
Executive Summary
One fatal, confirmed case of progressive multifocal leukoencephalopathy and one suspected case prompt withdrawal of multiple sclerosis product; risk/benefit ratio needs to be reestablished, companies say. Return to market would not be unprecedented, but Tysabri’s withdrawal sharpens focus on FDA's drug safety oversight.