Elan and Biogen hit by EU Tysabri questions

26 October 2009

The European medicines Agency's (EMEA) Committee for Medicinal Products for Human Use, (CHMP) Committee has started a review of the benefits and risks of Tysabri (natalizumab), in view of reports of 23 cases of progressive multifocal leukoencephalopathy (PML) worldwide since Tysabri has been on the market.

This review is initiated to discuss any additional measures necessary to ensure the safe use of Tysabri and how to balance the risks to the patients against the benefits of the treatment. Tysabri is indicated for patients suffering from highly active relapsing remitting multiple sclerosis with high disease activity despite treatment with a beta-interferon and for patients with rapidly evolving severe relapsing-remitting multiple sclerosis.

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