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US FDA continues to endorse Tysabri despite PML

This article was originally published in Scrip

Executive Summary

The US FDAcontinues to endorse monotherapy use of Biogen Idecand Elan's Tysabri (natalizumab) despite the occurrence of two cases of progressive multifocal leucoencephalopathy (PML) in patients who received the multiple sclerosis treatment as monotherapy. The agency is working with the companies to revise the Tysabri label to reflect that PML has occurred in patients receiving monotherapy. However, the agency "still believes that Tysabri monotherapy may confer a lower risk of PML than when Tysabri is used together with other immunomodulatory medications", the FDA said in an alert to healthcare professionals.



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