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The Food and Drug Administration (FDA) is reporting that Biogen-IDEC and Elan Corporation announced yesterday that FDA removed the clinical hold on Biogen-IDEC's studies of Tysabri (natalizumab) for patients with multiple sclerosis. This will allow clinical trials to go forward. In February 2005 Biogen-IDEC had announced suspension of marketing and clinical trials after three patients developed progressive multifocal leukoencephalopathy (PML), a frequently fatal infection of the brain, two following treatment with natalizumab for MS, and one patient being treated for Crohn's Disease. Two of these cases were fatal.
The removal of the clinical hold allows patients with MS who were previously treated with the drug under an investigational (IND) study to resume treatment in an IND study following discussion with their physicians about the potential risks and potential benefits of treatment.
Although this treatment has been shown to have benefit in patients with relapsing-remitting MS, concern about the risk of PML associated with use of Tysabri remains.
FDA has worked with Biogen-IDEC over the ensuing months to assess whether any other patients exposed to natalizumab had developed an early stage of PML, what factors might have been contributory to the three PML cases that did occur, to consider what procedures could be utilized to potentially decrease the risk of PML in the future, and how to suitably monitor patients to detect a PML infection as early as feasible.
The drug is not being placed back on the market at this time. FDA has scheduled an Advisory Committee Meeting on March 7 and 8, 2006 to discuss an application for Tysabri for use in treating patients with relapsing forms of multiple sclerosis. Aspects for discussion include the risks associated with the drug, its efficacy in the treatment of multiple sclerosis relapses and disability, its possible return to the marketplace, and its proposed risk management plan(s).
For further information, health care professionals and patients can visit FDA's website at: www.fda.gov/cder/drug/infopage/natalizumab/default.htm
Notice for the Peripheral and Central Nervous System Drugs Advisory Committee meeting: www.fda.gov/oc/advisory/accalendar/2006/cder12543d030706amd.html
Questions and Answers Regarding Lifting of the Clinical Hold on Tysabri (natalizumab)
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