Biogen Idec is seeking a revised license to sell the multiple sclerosis drug Tysabri. Biogen and Elan pulled the drug from the market earlier in the year after several patients on the drug contracted a rare brain disease. The application contained data from what Biogen billed as an extensive safety review of the drug. Biogen is also seeking an accelerated review of Tysabri, which could bring an FDA response within six months. The same data is being added to the drug company's European application, which is still pending. Analysts say that any renewed marketing of Tysabri is likely to come with a new warning label.
- read this article from the Boston Globe for more