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Natalizumab, sold under the brand name Tysabri among others, is a medication used to treat multiple sclerosis and Crohn's disease. [9] It is a humanized monoclonal antibody against the cell adhesion molecule α4-integrin . [ 9 ]
Tysabri is now distributed under a controlled prescription program called TOUCH (Tysabri Outreach: Unified Commitment to Health). [13] As of October 9, 2006, the FDA added a boxed warning to the anticoagulant warfarin due to the risk of bleeding to death. [14]
A few cases of skin cancer have been reported, which has also been reported in patients taking natalizumab (Tysabri), an approved multiple sclerosis drug. [7] Fingolimod has also been associated with potentially fatal infections, bradycardia and, in 2009, a case of hemorrhaging focal encephalitis, an inflammation of the brain with bleeding. [8]
TYSABRI ® (natalizumab) Data at ECTRIMS Reaffirm Positive Effects of Treatment for People with Relapsing Forms of MS -- Data demonstrate TYSABRI effect on Annualized Relapse Rates and EDSS scores ...
Biogen Idec and Elan Submit Applications for First-Line Use of TYSABRI in anti-JCV Antibody Negative Patients with MS - Marketing Applications Supported by Risk Stratification Data - WESTON, Mass ...
Tysabri is. Biotech firms Biogen Idec and Elan announced in a press statement released Wednesday that they have filed for regulatory approval to expand the use of multiple sclerosis drug Tysabri ...
Later, three typically sequential phases of testing in humans are common. Promising results regarding safety, efficacy, and side effects are generally needed at each major phase of development. Usually the regulatory agencies approve a multiple sclerosis medication for a specific clinical course.
For prescription medications, the insert is technical, providing information for medical professionals about how to prescribe the drug. Package inserts for prescription drugs often include a separate document called a "patient package insert" with information written in plain language intended for the end-user —the person who will take the ...
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