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Tysabri Multiple Sclerosis Clinical Trial Hold Lifted by FDA; Biogen Idec and Elan to Resume Clinical Trial Dosing in Multiple Sclerosis CAMBRIDGE, M.A., and DUBLIN, IRELAND -- February 15, 2006 -- Biogen Idec and Elan Corporation, plc. announced today that the Food and Drug Administration (FDA) informed the companies that they have removed the hold on clinical trial dosing of Tysabri® (natalizumab) in multiple sclerosis (MS) in the U.S. The companies expect to begin an open label, multi-center safety extension study of Tysabri monotherapy in the U.S. and internationally in the coming weeks. Patients who previously participated in the Phase III MS program are eligible for entry. Biogen Idec and Elan had previously voluntarily suspended Tysabri from the U.S. market and all ongoing clinical trials based on reports of progressive multifocal leukoencephalopathy (PML), a rare and potentially fatal, demyelinating disease of the central nervous system. Biogen Idec and Elan completed a comprehensive safety evaluation of more than 3,000 Tysabri patients in collaboration with leading experts in PML and MS. The results of the safety evaluation yielded no new confirmed cases of PML beyond the three previously reported. On September 26, 2005 the companies announced that they submitted a supplemental Biologics License Application to the FDA. Subsequently, the FDA designated Tysabri for Priority Review. The FDA grants Priority Review status to products that are considered to be potentially significant therapeutic advancements over existing therapies that address an unmet medical need. Based on the FDA's designation of Priority Review for Tysabri in MS, the companies anticipate action by the Agency approximately six months from the submission date, or by late March 2006. The FDA's Peripheral and Central Nervous System Drugs Advisory Committee will review Tysabri on March 7 and 8, 2006. SOURCE: Biogen Idec E-mail this page to a friend or colleague! To print, use this version