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February 28, 2005
Multiple Sclerosis Drug Tysabri Pulled Off Market
Biogen Idec and Elan announced Monday they have voluntarily withdrawn Tysabri, a drug used to treat multiple sclerosis, after one patient died and another developed a serious disease of the central nervous system after taking it in combination with Avonex for more than two years.
Tysabri was approved last November by the FDA after several years of clinical trials and is the first humanized monoclonal antibody approved for the treatment of MS. It acts by inhibiting adhesion molecules (docking devices) on the surface of immune cells lymphocytes.
Stocks of both companies were pounded in early trading today down 40% (BIIB) and 70% (ELN), respectively. The companies said in a news release that they have suspended supplying and marketing the drug and advised doctors to suspend prescribing the medication. The companies also have stopped using the drug in clinical trials.
MS affects over 400,000 Americans and over 2 million individuals worldwide.
CORRECTION/UPDATE 03/07: Due to an error in an Associated Press story on Friday, this blog incorrectly stated a second patient taking Tysabri had died as a result of PML. One patient died, while the second patient was confirmed to have contracted progressive multifocal leukoencephalopath.
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