** Stu's Views & M.S. News **: The FDA has approved the first test for assessing the risk of progressive multifocal leukoencephalopathy (PML) in patients on natalizumab (Tysabri)

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Friday, January 20, 2012

The FDA has approved the first test for assessing the risk of progressive multifocal leukoencephalopathy (PML) in patients on natalizumab (Tysabri)

By Kristina Fiore, Staff Writer, MedPage Today

Published: January 20, 2012

SOURCE: Medical News Today

The Stratify JCV Antibody ELISA test screens for the presence of antibodies to the JC virus, a risk factor for PML in patients with multiple sclerosis or Crohn's disease who are taking the monoclonal antibody, the agency said in a statement.

Natalizumab was pulled from the U.S. market in 2005 after the first of some 200 cases of PML came to light, but it was allowed back on the marketin 2006 after the development of a risk evaluation and mitigation strategy (REMS).

Risk of PML should be calculated not only by the antibody test results, but should also be based on the length of time the patient has been on natalizumab (more than two years increases the risk) and if the patient is taking other immunosuppresants, the FDA said.

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Disclaimer: 'MS Views and News' (MSVN), does not endorse any products or services found on this blog. It is up to you to seek advice from your healthcare provider. The intent of this blog is to provide information on various medical conditions, medications, treatments, and procedures for your personal knowledge and to keep you informed of current health-related issues. It is not intended to be complete or exhaustive, nor is it a substitute for the advice of your physician. Should you or your family members have any specific medical problem, seek medical care promptly.

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