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Page: << Prev | 1 | 2 | 3 | Next >> In June 2006, the FDA allowed the drug to return to the market, but with strict conditions. According to the new guidelines, Tysabri can only be administered by approved doctors, at infusion sites and pharmacies that register and comply with a patient-safety program designed by Biogen-IDEC, the maker of Tysabri, and approved by the FDA.
According to the U.S. National Institutes of Health, multiple sclerosis is an unpredictable disease of the central nervous system that can range from relatively benign to somewhat disabling, to devastating, as communication between the brain and other parts of the body is disrupted.
Many researchers believe MS to be an autoimmune disease, one in which the body, through its immune system, launches a defensive attack against its own tissues. In the case of MS, it is nerve-insulating myelin tissue that is under assault.
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This trial was initiated after a neuroradiologist noticed that some patients were developing new lesions (as evidenced on MRI) after their Tysabri was discontinued.
All participants in this trial had had MRIs of their brains taken before starting Tysabri. They then had another such scan taken an average of 15 months after receiving the last infusion of the drug.
Participants were divided into two groups -- one which had taken the drug for an average of three years and one which had taken Tysabri for an average of only two months.
MRI scans revealed that participants developed more than triple the number of brain lesions (damaged areas) in the 15-month period since stopping the drug than they had developed before starting it. Those who had taken the drug for the shorter interval showed the most disease activity.
"Virtually all of the high-rebound figure came from the group that had a mean duration of therapy of only two months. I think that's relatively reassuring for the drug," Richert said.
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