Elan/Biogen to submit supplemental license application for ms drug Tysabri to FDA

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Elan/Biogen to submit supplemental license application for ms drug Tysabri to FDA
By Finfacts Team
Sep 21, 2005, 09:59

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On February 28, 2005, Biogen Idec and Elan announced that they voluntarily suspended TYSABRI from the U.S. market

Irish drugs firm Elan Corporation and US biotech firm Biogen Idec announced today that in the coming weeks they expect the safety evaluation of TYSABRI (natalizumab) in Crohn's disease and rheumatoid arthritis will be completed, and that they will submit a supplemental Biologics License Application for TYSABRI in multiple sclerosis (MS) to the U.S. Food and Drug Administration (FDA).

On August 9, 2005, the companies announced the completion of the safety evaluation of TYSABRI in MS, which resulted in no new confirmed cases of progressive multifocal leukoencephalopathy (PML). The companies have previously reported three confirmed cases of PML, two of which were fatal.

On February 28, 2005, Biogen Idec and Elan announced that they voluntarily suspended TYSABRI from the U.S. market and all ongoing clinical trials based on reports of PML, a rare and potentially fatal, demyelinating disease of the central nervous system.