ELAN has said it has no plans to introduce a European version of a US patient-monitoring programme which has been credited with cutting the prevalence of an often fatal side effect, the brain infection PML, among patients taking its flagship drug Tysabri.
Some analysts believe the programme may be a reason why only 20% of the PML cases reported among Tysabri users over the past year have occurred in the US.
Sure wuld be nice if Elan could provide comments to patients on why they didn't believe a US TOUCH type monitoring program was not necessary.
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Elan and Biogen are performing extensive work into the potential risk factors for developing PML based on the cases seen to date. This work may be providing better methods for risk assessment/early PML detection that the existing US TOUCH program.