(Long Island, N.Y.) The Food and Drug Administration released in a public approval letter the drug called Tysabri of Biogen and Elan Laboratories for use on patients with Crohn’s disease in the U.S. that won’t respond to more conventional and safer drugs such as Humira by Abbott Laboratories.
Tysabri is a monoclonal antibody that affects the actions of the body’s immune system that is used to help in treating relapsing forms of Multiple Sclerosis. In 2005, the drug was pulled off the market after at least three patients reportedly developed multifocal leukoencephalopathy or PML which is a rare and usually fatal viral disease that is characterized by progressive damage or inflammation of the white matter of the brain at multiple locations. It occurs almost exclusively in people with severe immune deficiency, e.g. transplant patients on immunosuppressive medications, or AIDS patients.
The following year, Tysabri was allowed to be used but under a more scrutinized environment and only after the patient passed a stringent test available only to select patients through a restricted-use program called the TOUCH Prescribing Program. To receive this medication, you would have to be enrolled in this program and meet all requirements. You would be interviewed before receiving each dose of the medicine to make sure you still meet the requirements. The Drug is reportedly being used by more than 12,000 multiple Sclerosis patients in the United States with no fatal disorders reported since the new measures where implemented.
Over 500,000 people in the U.S. suffer from Crohn’s disease which is a chronic, episodic, inflammatory condition of the gastrointestinal tract characterized by affecting the entire wall of the involved bowel or intestines. It causes Diarrhea, fever and internal bleeding with no known cure. The release of Tysabri will help ease Crohn’s disease patient’s when taking the drug and it will be competing directly with Remicade made by Johnson and Johnson’s in the U.S. for Crohn’s disease. Release of Tysabri for Crohn’s disease patients will start next month.
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