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Tysabri resubmission

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Biogen Idec and Elan are requesting a priority review for their resubmission of multiple sclerosis therapyTysabri (natalizumab). The sBLA submission, announced Sept. 26, includes a risk management plan with a patient registry, revised labeling, final two-year data from the Phase III AFFIRM monotherapy trial and SENTINEL add-on study with Avonex (interferon beta-1a), as well as an integrated safety assessment of all patients treated with the biologic in clinical trials. The safety data set includes not only the MS pivotal trials but also Crohn's disease and rheumatoid arthritis trials (1Pharmaceutical Approvals Monthly August 2005, In Brief). Biogen Idec previously stated it expects an advisory committee review of the resubmission. Tysabri was withdrawn from the market in February following reports of progressive multifocal leukoencephalopathy from clinical trials...
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