Biogen Idec and Genentech have warned doctors that two patients taking Rituxan for lupus have died of a rare brain infection called progressive multifocal leukoencephalopathy, or PML. Rituxan is approved for non-Hodgkin's lymphoma and rheumatoid arthritis and cancer patients have already been warned about their risk of PML. One analyst noted that the new risk for lupus may make it harder for the companies to gain approval to use Rituxan for lupus and M.S. Biogen Idec has also had to deal with the risk of PML [1] raised by its MS drug Tysabri. That drug was withdrawn until a new safety program was assembled.
- read the FDA's warning [2] on the drug
- here's the report [3] from The New York Times
Related Articles:
Rituxan data encourages researchers. Report [4]
FDA approves Rituxan for rheumatoid arthritis. Report [2]
FDA allows Tysabri back on the market. Report [5]
Links:
[1] http://www.fiercebiotech.com/story/tysabri-linked-to-new-infection/2005-06-13
[2] http://www.fiercebiotech.com/node/4994
[3] http://www.nytimes.com/2006/12/19/health/19lupus.html
[4] http://www.fiercebiotech.com/story/spotlight-rituxan-data-encourages-researchers/2006-08-28
[5] http://www.fiercebiotech.com/story/fda-allows-tysabri-back-on-market/2006-06-06