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The U.S. Food and Drug Administr ...

Posted Nov 10 2008 4:21pm

The U.S. Food and Drug Administration has approved Tysabri (natalizumab) for the treatment of moderate-to-severe Crohn's disease in patients with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional Crohn's disease therapies.

Crohn's disease patients using the drug must be enrolled in a special restricted image distribution program called the Crohn's Disease-Tysabri Outreach Unified Commitment to Health (CD TOUCH) Prescribing Program.   The approval is consistent with an agency advisory committee recommendation to approve Tysabri for use in Crohn's patients. Tysabri was approved by the FDA in June 2006 to treat relapsing forms of multiple sclerosis. 

Crohn's disease is a chronic, inflammatory bowel disease that affects both men and women. There is no cure. Crohn's can cause diarrhea, fever, rectal bleeding, malnutrition, narrowing of the intestinal tract, obstructions, abscesses, cramping, and abdominal pain. The disease also can lead to abnormal connections (fistulas) leading from the intestine to the skin or internal organs. Its cause is unknown. There are more than 1 million people with Crohn's disease worldwide.

FDA approves Tysabri to treat Crohn's disease

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