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Journal releases reports early after fourth Tysabri patient develops brain infection
June 9, 2005
Tysabri was FDA approved in November 2004 for the treatment of multiple sclerosis and Crohn's disease, but last February, Elan Corp. and Biogen Idec Inc., which marketed the drug, withdrew it after reports that three patients taking it had developed a degenerative brain infection that is often fatal called progressive multifocal leukoencephalopathy (PML).
The New England Journal of Medicine released detailed reports in three scientific briefs and two editorials early after a possible fourth case was reported last week. Two of the three patients have died.
There is still a possibility that Tysabri could return to the market if screening methods are found to detect which patients might be susceptible to the brain infection. The Multiple Sclerosis Society vice president for research and clinical programs, Dr. John R. Richert, says it is the first time the group has had a peer-reviewed report of the information provided by the company to the public.
Richert said the journal reports provide two significant pieces of information that were not previously available, one of which he believes raises the possibility that diagnosis of the infection could be possibly earlier than expected in people at risk. Still, Richert acknowledges it could be a long time before Tysabri is allowed back on the market, if ever.
Because PML is a difficult infection to accurately diagnosis, it could take time to determine if the fourth patient who took Tysabri actually developed the brain infection or not.
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