Tysabri update.Safety results and final data from studies of Tysabri (natalizumab) for use by people with MS were presented to the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. for evaluation in early fall by giogen Idec and Elan Corporation, Tysabri's sponsors. Based on these results, the FDA agreed to fast-track their review. Tysabri was suspended in 2005 following the diagnosis of PML PML - Parallel ML. ["Synchronous Operations as First-Class Values", J.H. Reppy <jhr@research.att.com>, Proc SIGPLAN 88 Conf Prog Lang Design and Impl, June 1988, pp. 250-259]. (progressive multifocal leukoencephalopathy Progressive Multifocal Leukoencephalopathy Definition Progressive multifocal leukoencephalopathy (PML) is a rapidly progressive neuromuscular disease caused by opportunistic infection of brain cells (oligodendrocytes and astrocytes) by the JC virus ) in two people being given a Tysabri and Avonex combination. According to the companies, there have been no new cases of PML in people with MS. Safety studies of Tysabri in Crohn's disease Crohn's disease: see colitis. and arthritis complete In October, Biogen and Elan announced that their safety evaluation of Tysabri in people with Crohn's disease and rheumatoid arthritis rheumatoid arthritis Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course. is now complete. As with the safety study in MS, they reported finding no new confirmed cases of PML in people with Crohn's disease or arthritis. According to the sponsors, they have requested a priority review of an application to reintroduce Tysabri to the market. "We look forward to seeing the full safety and efficacy data and to seeing the results of the FDA's safety review," said John Richert, MD, National MS Society vice president of Research and Clinical Programs. The Society will keep you posted on future developments. |
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