European Drug Agency To Weigh Risks/Benefits Of Tysabri -- Cites 23 Cases Of PML

Main Category: Multiple Sclerosis
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 27 Oct 2009 - 4:00 PDT

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Today the EMEA, the European equivalent of the U.S. Food and Drug Administration, released a statement indicating that one of its advisory committees was launching a review of the risks and benefits of Tysabri® (natalizumab, Biogen Idec and Elan Pharmaceuticals) in light of 23 confirmed cases of PML that it says have occurred since the drug has been on the market. PML (progressive multifocal leukoencephalopathy) is a viral infection of the brain that usually leads to death or severe disability. (This number of cases is still within the anticipated frequency of 1 in 1,000 indicated in the drug's labeling.)

Unlike the situation in the U.S, there is no unified risk management strategy in place across Europe for the administration of Tysabri. In the U.S., the drug is administered only to patients registered with the company's TOUCH program.

The National MS Society will follow the European panel's deliberations on the safety of Tysabri and any new thoughts they might have on balancing the risks and benefits of this therapy for people with MS.

Source
National MS Society