Tuesday, May 29, 2007
DUBLIN, Ireland -- Elan Corp. and Biogen Idec Inc., co-makers of Tysabri, announced Tuesday that U.S. regulators soon would review the drug for its possible use by sufferers of the gastrointestinal Crohn's disease.
Both companies said two review committees of the U.S. Food and Drug Administration would jointly consider July 31 whether to permit sale of Tysabri to treat Crohn's, which causes chronic but nonfatal inflammation of the intestines and afflicts one million people world-wide.
Clinical trials of Tysabri -- which last year was approved for use in the United States and European Union to combat the most advanced cases of multiple sclerosis _ have indicated that the drug is effective in preventing inflammatory immune cells from penetrating the wall of the intestine, limiting the damage they can cause.
Tysabri's use for MS patients has been heavily restricted because of its link to a rare, usually fatal disease of the central nervous system called progressive multifocal leukoencephalopathy, or PML. Both companies temporarily withdrew the drug from sale in February 2005 after three patients in clinical trials contracted PML; two, including a Crohn's sufferer, died.
Elan of Dublin, Ireland, and Biogen Idec of Cambridge, Mass., in December applied for FDA approval of Tysabri for Crohn's sufferers.
The disease most commonly develops in people in their teens and 20s and has no cure. It can cause diarrhea, abdominal cramps, fever and bowel obstructions, leading to lost appetite and weight.
The leading current treatment for Crohn's is Remicade, manufactured by Johnson & Johnson. Analysts say, if given FDA approval, Tysabri probably would be prescribed only to those Crohn's sufferers who were not responding to treatment from longer-established, lower-risk drugs.
Copyright © 2007 Associated Press