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Evaluation of patients treated with natalizumab finds no new cases of PML

An independent clinical and laboratory study of more than 3000 people treated with the drug natalizumab (Tysabri) for multiple sclerosis (MS), Crohn's disease, and rheumatoid arthritis has found no evidence of new cases of the often-fatal disorder called progressive multifocal leukoencephalopathy (PML). The laboratory component of the study was coordinated by the National Institute of Neurological Disorders and Stroke (NINDS) at the National Institutes of Health (NIH), working in conjunction with the NIH Clinical Center. Clinical and neuroradiological experts from other institutions also participated. Results of the study will be published in the March 2, 2006, issue of the New England Journal of Medicine.*

Natalizumab, an immune system-modifying drug, was approved by the U.S. Food and Drug Administration in November 2004 to treat relapsing-remitting MS. Studies have shown that it can substantially reduce the frequency of relapses in that disease. However, the drug was withdrawn from the market and from clinical trials in February 2005 after the manufacturer identified 2 cases of PML in MS patients who had received the drug. A person with Crohn's disease who had received natalizumab was also diagnosed with PML. The current study was conducted to determine whether other people treated with natalizumab were at risk of PML. Symptoms of PML include mental deterioration, problems with vision, speech, balance, and movement, and, in most cases, coma and death.

"This was an important opportunity for NIH to use its specialized expertise in cooperation with the private sector to address a pressing and unanticipated risk of a devastating disorder," said NIH Director Elias A. Zerhouni, M.D.

"This study was designed to address a critical, immediate need for patient safety in the people who participated in clinical trials of this drug," says Eugene Major, Ph.D., of NINDS. "We had to assess who else might be at risk." Dr. Major served as the cha
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Contact: Natalie Frazin or Paul Girolami
301-496-5924
NIH/National Institute of Neurological Disorders and Stroke
1-Mar-2006


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