Tysabri for Crohn's disease sBLA submitted to FDA
Irish biotechnology company Elan and USA-based pharmaceutical firm Biogen Idec say that they have completed the submission of a supplemental Biologics License Application to the US Food and Drug Administration that requests approval for Tysabri (natalizumab) as a treatment for moderate to severely active Crohn's disease. The firms added that the drug is currently approved in the USA as a therapy for relapsing forms of multiple sclerosis and in Europe as a single disease-modifying agent for highly active relapsing-remitting forms of the autoimmune condition.
The filing is based on data from three randomized, double-blind, placebo-controlled multicenter trials of the drug (ENCORE, ENACT-1 and ENACT-2), which were designed to assess its safety and efficacy as both an induction treatment and as maintenance therapy in Crohn's disease (Marketletter October 30, 2006).
sBLA includes PML information
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