Withdrawn MS drug returns to market

May 24, 2007

Dallas - May 23, 2007 -- Just months after receiving FDA approval, natalizumab, a medication for the treatment of multiple sclerosis (MS) and other inflammatory disorders, was voluntarily withdrawn by its manufacturers after three patients developed a brain infection known as Progressive Multifocal Leukoencephalopathy (PML). Natalizumab has recently been re-approved by the FDA, and a comprehensive article published in the latest issue of CNS Drug Reviews provides a timely overview of the drug, its pharmacological properties, clinical efficacy, safety and toxicology.

MS is a disorder that affects the central nervous system, with leukocytes (inflammatory cells) attacking the body's neurons and causing serious damage. A highly effective immunosuppressive treatment, natalizumab is an antibody that prevents leukocytes from crossing blood vessel walls into tissues such as the brain and spinal cord. The drug may also benefit secondary lymphoid organs, such as lymph nodes and the spleen, and inhibit reactivation in the central nervous system. It has been shown to significantly reduce leukocyte cell numbers in spinal fluid, with benefits continuing for six months after treatment.

"The release of natalizumab ushers in a new era in the treatment of MS," says Dr. Olaf Stüve , author of the study, noting, however, that while the short-term risk-benefit ratio appears positive, the long-term risks remain unknown. "As therapy with natalizumab resumes worldwide, the neurologic community will garner more information about the long-term risks and benefits of this powerful therapeutic medication," but for now natalizumab use is being strictly monitored. Both the FDA and TOUCH, a special distribution program designed to prevent patients not qualified for the treatment from receiving the drug, are working to make sure that any potential infectious complications are identified as early as possible.
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This study is published in Vol. 13 Issue 1 of CNS Drug Reviews. Media wishing to receive a PDF of this article may contact medicalnews@bos.blackwellpublishing.net.

Olaf Stüve, M.D., Ph.D. is an Assistant Professor in both the Department of Neurology and at The Center for Immunology at the University of Texas Southwestern Medical Center at Dallas. He is also a Staff Physician in the Neurology Section at VA North Texas Health Care Systems. He can be reached for questions at olaf.stuve@utsouthwestern.edu

CNS Drug Reviews focuses on extensive reviews on the pharmacology, pharmacokinetics, toxicology and clinical trials of new drugs affecting the central nervous system. These peer reviewed articles are written by industrial or academic scientists who participated in the development of a particular drug. The Editorial Board is composed of eminent and highly reputable scientists. For more information, please visit www.blackwell-synergy.com/loi/cns.

Blackwell Publishing is the world's leading society publisher, partnering with 665 medical, academic, and professional societies. Blackwell publishes over 800 journals and has over 6,000 books in print. The company employs over 1,000 staff members in offices in the US, UK, Australia, China, Singapore, Denmark, Germany, and Japan and officially merged with John Wiley & Sons, Inc.'s Scientific, Technical, and Medical business in February 2007. Blackwell's mission as an expert publisher is to create long-term partnerships with our clients that enhance learning, disseminate research, and improve the quality of professional practice. For more information on Blackwell Publishing, please visit www.blackwellpublishing.com or www.blackwell-synergy.com.

Blackwell Publishing Ltd.

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