Tysabri filed with FDA for Crohn's

Ireland's Elan Corp and US biotechnology firm Biogen Idec have submitted a supplemental Biologics License Application to the US Food and Drug Administration seeking approval to market Tysabri (natalizumab) as a treatment for patients with moderately to severely active Crohn's disease.

The filing is based on the results of three randomized, double-blind, placebo-controlled, multicenter trials of Tysabri assessing the safety and efficacy as both an induction and maintenance therapy - ENCORE (Efficacy of Natalizumab in Crohn's Disease Response and Remission), ENACT-1 (Efficacy of Natalizumab as Active Crohn's Therapy) and ENACT-2 (Evaluation of Natalizumab As Continuous Therapy). The filing also includes proposed labeling and a risk management plan, both of which are similar to those approved for the drug's multiple sclerosis indication.