09 November 2009
Elan & Biogen-Idec have made changes to the label on Natalizumab to reflect the increased risk of PML over a longer period of time. They are updating the label following consultation with the FDA; “risk of developing progressive multifocal leukoencephalopathy increases with longer treatment duration, and for patients treated for 24 to 36 months is generally similar to the rates seen in clinical trials. There is limited experience beyond three years of treatment”.
Source Pharma Times: http://www.pharmatimes.com/WorldNews/article.aspx?id=16874