Monday, January 08, 2007

Elan And Biogen Idec Submit Supplemental Biologics License Application To The Fda For The Approval Of Tysabri® As A Treatment For Crohn's Disease

Dublin, Ireland and Cambridge, MA - December 15, 2006 - Elan Corporation, plc (NYSE: ELN) and Biogen Idec (NASDAQ: BIIB) announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval to market TYSABRI® (natalizumab) in the U.S. as a treatment for patients with moderately to severely active Crohn's disease (CD).The filing is based on the results of three randomized, double-blind, placebo-controlled, multi-center 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 multiple sclerosis indication.
Read More

No comments: