A European panel has started a review of the controversial multiple sclerosis drug Tysabri, sold by Biogen Idec Inc. and Elan PLC, citing a higher rate of a rare brain infection than previously disclosed.
The additional cases are important because they may increase the drug's risk profile and raise questions about the companies' responsibility in updating the market on the safety record of Tysabri, a product that generates nearly $1 billion in yearly revenue.
The European Medicines Agency's Committee for Medicinal Products for Human Use, known as CHMP, reported there have been 23 cases of progressive multifocal leukoencephalopathy, or PML, ... full story in TheWall Street Journal
