Adverse Drug Reaction

Tysabri safety evaluation complete; no new confirmed cases of PML

Published in Gastroenterology Week, November 14th, 2005

Elan Corp., plc, (ELN) and Biogen Idec (BIIB) announced that findings from their safety evaluation of Tysabri (natalizumab) in patients with Crohn disease (CD) and rheumatoid arthritis (RA) resulted in no new confirmed cases of progressive multifocal leukoencephalopathy (PML).

The companies have previously reported that findings from their safety evaluation of Tysabri in patients with multiple sclerosis (MS) resulted in no new confirmed cases of PML. Three confirmed cases of PML were previously reported, two of which were fatal. The Tysabri safety evaluation is now complete.

On September 26, 2005 the companies announced that they submitted a...

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Source: Gastroenterology Week (2005-11-14)

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