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FDA to weigh Tysabri fate

January 30, 2006 | A version of this story appeared in Volume 84, Issue 5

An FDA committee will decide on March 7 whether the agency should allow the multiple sclerosis drug Tysabri back on the market. Sales of Tysabri, a monoclonal antibody codeveloped by Biogen Idec and Elan, were suspended in February 2005 after the drug was linked to progressive multifocal leukoencephalopathy, a rare nervous system disorder. Last fall, the companies submitted two-year Phase III data and more safety information on patients in the trial. They have also suggested revisions to the drug's label and have proposed a patient-monitoring program.

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