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1ST TIME HERE?.....CLICK THE FLASHING RED BUTTON ON THE LEFT! | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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August 09, 2005MS BREAKING NEWS: TYSABRI: Letter to Healthcare Professionals
From: Gordon Francis, MD, Vice President, Neurology Therapeutic Market, Elan Pharmaceuticals:
"Dear Healthcare Professional, In an effort to keep you informed of new developments, Biogen Idec and Elan Pharmaceuticals are providing an update related to the ongoing safety evaluation of TYSABRI® (natalizumab). On August 9, 2005, we announced that findings from our ongoing safety evaluation of TYSABRI revealed no new confirmed cases of progressive multifocal leukoencephalopathy (PML) in multiple sclerosis (MS). The Crohn’s disease and rheumatoid arthritis safety evaluation is on track to be completed by the end of the summer. More than 2,000 MS clinical trial patients were eligible for the TYSABRI safety evaluation. 91% of these patients chose to participate in the evaluation. Of these participating patients, 99% had a neurological exam, and 98% had an MRI. The safety evaluation also included the review of any reports of potential PML in patients receiving TYSABRI in the commercial setting. On February 28, 2005, we announced the voluntary suspension of TYSABRI from the US market and all ongoing clinical trials based on reports of PML, a rare and potentially fatal demyelinating disease of the central nervous system. The companies have previously reported three confirmed cases of PML, two of which were fatal. We remain committed to completing this safety evaluation and look forward to working with regulatory agencies to determine the appropriate path forward for TYSABRI. Based on expected completion of the safety assessment by the end of the summer, we anticipate making regulatory submissions to the U.S. Food and Drug Administration (FDA) by early fall. Thank you for your patience and continued support over the past few months. We will continue to inform you of new developments and changes. For additional questions, please contact Medical Information at" |