FDA to Weigh Tysabri for Crohn's Disease

Source: http://www.ibtimes.com/articles/20070529/elan-biogen-tysabri.htm

Elan Corp. PLC and Biogen Idec Inc., the makers of Tysabri, announced Tuesday that U.S. regulators would soon review the drug for its possible use by sufferers of the gastrointestinal ailment Crohn's disease.

Both companies said two review committees of the U.S. Food and Drug Administration would jointly consider on July 31 whether to permit sale of Tysabri to treat Crohn's, which causes chronic but nonfatal inflammation of the intestines and afflicts 1 million people worldwide.

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.

Both MS and Crohn's are diseases that cause the immune system to attack the body's soft tissues, including those that line the intestines and nerves.

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., applied in December 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 decreased 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.

Elan shares fell 0.03 euros ($0.04) to 14.15 euros ($19.09) on the Irish Stock Exchange.