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Biogen Idec and Elan Pharmaceuticals informed drug regulatory authorities about two new confirmed cases of PML in individuals who were taking Tysabri® (natalizumab) as a monotherapy (not in combination with other therapies).
PML (progressive multifocal leukoencephalopathy) is a viral infection of the brain that usually leads to death or severe disability. Although FDA prescribing information includes a black box warning about the risk of PML, the three previous cases of PML that occurred in the context of clinical trials were in patients who had taken Tysabri in association with other immune-modulating or immune-suppressing medications.
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Comments from other MS societies:
UK MS Society
MS Ireland
MS Australia
Source: US National MS Society
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