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Article: United States: Biogen Updates Tysabri Label To Reflect Risk With Longer Use.

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TendersInfo
Article date:
November 9, 2009
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Byline: prashant03

Biogen Idec Inc. (BIIB) amended the U.S. label of multiple sclerosis treatment Tysabri, sold with Elan Corp. PLC (ELN), on Friday to reflect that the risk of a rare brain infection rises with longer usage.

The changes, which were expected, note that the occurrence of progressive multifocal leukoencephalopathy, or PML, in patients treated for 24 to 36 months is "generally similar" to the 1-in-1,000 rate seen in clinical trials. The changes warn that there is limited experience with the drug beyond three years of treatment.

Lazard Capital Markets' analyst Joel Sendek said the changes appeared to be benign. "We do not expect ...

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