PML News

MS Drug Tysabri Not Yet Reinstated Due to PML Fears

At a glance:

A controversial drug for multiple sclerosis is not yet back on the market.
 
Tysabri was available in the US for only three months when it was recalled due to concern that it was linked to cases of a rare brain disease, progressive multifocal leukoencephalopathy (PML).
 
An FDA advisory panel recommends reinstatement in view of its success treating MS and the lack of any new cases of PML, but the FDA has delayed the decision until June.


Ruling on MS Drug Tysabri Delayed

Los Angeles Times - 3/23/2006 3:03 AM

In November 2004, the FDA approved Tysabri for sale to the approximately 350,000 people in the United States who suffer from MS, an incurable disease of the central nervous system.
 
But Elan and Biogen withdrew the drug three months later, after three people taking Tysabri in clinical trials contracted a rare, often fatal brain disease called progressive multifocal leukoencephalopathy, or PML. Two of them died. Both companies subsequently said they found no additional PML cases amon

 
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