The FDA has decided to allow Biogen Idec and Elan to use Tysabri in clinical trials under limited circumstances, which many analysts see as a step toward eventually allowing the multiple sclerosis drug back on the market. For now, the agency says it will allow the use of Tysabri among trial patients who had earlier shown signs of benefiting from the drug. The FDA will decide whether or not it will allow Tysabri back on the market--possibly in some limited fashion--by the end of March. Tysabri was approved in November 2004 and abruptly jerked from the market a few months later after several patients taking the drug contracted a rare brain disease called PML. Two of those patients died. Researchers say they'll start a trial with Tysabri that closely monitors for PML. The drug will be studied alone. Both of the MS patients that suffered from PML had been taking a combination of Tysabri and Avonex.
- read this article [1] from The New York Times
ALSO: Biogen Idec reported that fourth quarter sales nearly doubled on rising income from its old MS drug and Rituxan. Report [2]
Links:
[1] http://www.nytimes.com/2006/02/16/business/16drug.html
[2] http://www.newratings.com/analyst_news/article_1207885.html