Wednesday, 13 February 2008

Tysabri Approved for Chrones Disease Treatment

People with Chrones Disease have some excellent news in that the US Food and Drug Administration has approved the use of a drug called Tysabri (natalizumab) to treat people with chrones disease who have not yet responded to other forms of treatment.

Tysabri has potentially some pretty serious side effects and because of this people with chrones disease who are using the drug Tysabri will also be enrolled in a program that restricts distribution called Crohn's Disease-Tysabri Outreach Unified Commitment to Health (CD-TOUCH). Some of the possible side effects of Tysabri include anaphylactic reactions,possible liver injury, progressive multifocal leukoencephalopathy (a viral infection that affects the brain. This viral infection could cause severe disability or even death.)

The CD-TOUCH program will allow physicians to check people with chrones disease that are using Tysabri after three months, if there is no sign of improvement Tysabri will no longer be perscribed.

Tysabri was approved way back in 2006 for the treatment of patients suffering from elapsing multiple sclerosis and now has to go ahead to be used on Chrones Disease sufferers. It is produced by Elan, a company based in Ireland as well as Biogen Idec in the US and will used on patients with chrones who have yet to respond to any other forms of treatment

What is Chrones Disease?
Chrones Disease affects the bowel. It is incurable and the symptoms include diarrhea, fever, rectal bleeding, malnutrition, narrowing of the intestines, cramping, and abdominal pain. More than 1 million people around the world have chrones disease.

The disease can also lead to abnormal connections in the gut which are called fistulas these connections grow from the intestines to the skin or internal organs.

Details of the Drug
Drug Name: TYSABRI (Brand Name Drug)
FDA Application No. (BLA) 125104
Active Ingredient: NATALIZUMAB
Original Approval or Tentative Approval Date: November 23, 2004

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