• Giuseppe TridenteEmail author


Natalizumab (Tysabri®, Elan, Biogen) is a recombinant humanized IgG4 murine antibody binding to α4β1 and α4β7 integrins. In November 2004, FDA granted approval for treatment of relapsing forms of multiple sclerosis (MS). However, as soon as February 2005 the Agency suspended the marketing due to two cases of progressive multifocal leukoencephalopathy (PML) in MS-treated patients, but readmitted the biomedicine in 2006 with a mandatory restriction of participation to a RiskMAP (TOUCH) distribution program, to assess and minimize the risk of PML and other serious AEs. During 2006, EMEA examined the requests for approval in MS and in Crohn’s disease (CD), and granted approval for rapidly evolving severe relapsing-remitting MS and for highly active relapsing-remitting MS resistant to IFNβ, but rejected the CD indication, which was re-examined in 2008 with confirmed refusal. In 2006, Health Canada approved natalizumab for treatment of MS in patients with inadequate response or intolerance to other therapies for that disease. The Japanese PMDA approved natalizumab in MS patients in 2008.


Multiple Sclerosis Multiple Sclerosis Patient Progressive Multifocal Leukoencephalopathy Glatiramer Acetate Immune Reconstitution Inflammatory Syndrome 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Supplementary material

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Supplementary material 1 (XLS 91.5 kb)


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Copyright information

© Springer-Verlag Italia 2014

Authors and Affiliations

  1. 1.University of VeronaVeronaItaly

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