European Medicines Agency issues recommendations following review of Tysabri and PML risk

The European Medicines Agency said on Thursday that it finalised a review of Biogen Idec and Elan's Tysabri (natalizumab) and the risk of progressive multifocal leukoencephalopathy (PML) in patients taking the drug. Its assessment found that the drug's benefits "continue to outweigh its risks for patients with highly active relapsing-remitting multiple sclerosis," however the agency recommended that a number of measures be implemented to manage the risk.

The regulator explained that its review found that the risk of PML "remains low" in patients taking Tysabri. The latest data showed that of the 31 cases of PML recorded worldwide since July 2008 in patients taking the drug, 23 cases have been in patients treated for more than two years. The agency recommended that the prescribing information for Tysabri be updated to mention the increased risk of PML after two years.

Among the other recommendations, the EMEA said more advice should be added to the product label concerning how to manage patients who show signs of the brain infection.

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