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Natalizumab, a selective adhesion-molecule inhibitor, was introduced to the U.S. market for the treatment of relapsing-remitting multiple sclerosis (RRMS) in November 2004, then withdrawn in February 2005 after progressive multifocal leukoencephalopathy (PML) occurred in three trial participants, two with MS (see JW Neurol Jul 7 2005). It was reintroduced in July 2006 with a risk-management program (see JW Neurol Jun 26 2007). Now, members of the Therapeutics and Technology Assessment Subcommittee (TTAS) of the American Academy of Neurology have provided an evidence-based report on the use of natalizumab for treating MS.
The authors categorized as level A the evidence that, in RRMS, natalizumab reduces measures of disease activity (including…