| Biogen
Idec and Elan announced on 28 February 2005 the voluntary
suspension of US marketing of natalizumab (TYSABRI) for
the treatment of multiple sclerosis (MS). Furthermore, the
companies have suspended dosing of the agent in all clinical
trials. This decision was taken based on two confirmed cases
of progressive multifocal leukoencephalopathy (PML) in patients
treated with natalizumab and AVONEX. The companies will
work with the FDA to determine the possibility of future
availability of the product.
Natalizumab,
a humanized monoclonal antibody targeting the cell adhesion
receptors alpha4 and beta1 and alpha4 beta7 integrins, was
launched in the USA December 2004. Approval was pending
in Canada and the EU. The product was also awaiting approval
in the EU as a therapy for Crohn’s disease. Natalizumab
was undergoing phase III and phase II evaluation in Crohn’s
disease and rheumatoid arthritis, respectively.
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