FDA C'tee to review Tysabri for Crohn's

Ireland-based Elan Corp and US firm Biogen Idec say that the Gastrointestinal Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee of the US Food and Drug Administration will jointly review their Tysabri (natalizumab) for the treatment of Crohn's disease on July 31.

On December 15, 2006, the companies announced that they submitted to the FDA a supplemental Biologics License Application for the drug as a treatment for moderately-to-severely-active Crohn's disease. This sBLA includes 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 sBLA includes data from more than 1,500 Crohn's patients treated with the drug, as well as proposed labeling and a risk management plan. Tysabri is a humanized monclonal antibody believed to block entry of inflammatory immune cells into the wall of the intestine, thus limiting inflammatory damage in Crohn's disease. It is the first potential treatment for Crohn's disease with this proposed mechanism of action, the firms contend.