The Medical Letter on Drugs and Therapeutics
In Brief: Natalizumab (Tysabri) Returns
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Soon after The Medical Letter first reviewed use of natalizumab (Tysabri – Biogen Idec and Elan) for treatment of relapsing forms of multiple sclerosis (MS) (Med Lett Drugs Ther 2005; 47:13), the drug was withdrawn from the market. The unpublished clinical trials that led to its approval by the FDA have since been published, and now the drug has been returned to the market with prescribing restrictions.

Natalizumab decreases the number of relapses and new brain lesions in patients with MS. It was withdrawn because progressive multifocal leukoencephalopathy (PML) occurred in 3 (of about 3000) patients being treated with the drug; two were taking the drug in combination with interferon beta for MS, and one was taking it with azathioprine for Crohn’s disease. PML is an opportunistic infection of the brain, caused by reactivation of the JC virus in immunosuppressed patients, that ... more      

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Title: In Brief: Natalizumab (Tysabri) Returns
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