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Title: FDA to Amend Natalizumab Label Based on New Cases of PML in Europe

"FDA to Amend Natalizumab Label Based on New Cases of PML in Europe"

ROCKVILLE, Md -- August 25, 2008 -- The US Food and Drug Administration (FDA) has recently received information about 2 new cases of progressive multifocal leukoencephalopathy (PML) in patients receiving natalizumab injection (Tysabri) monotherapy for multiple sclerosis (MS) in Europe. Both patients had received natalizumab for more than 1 year. Although PML is a known risk of natalizumab treatment, previous cases in patients with multiple sclerosis were seen in combination with other immunomodulatory therapies. No new cases have been seen in the United States, where about 7,500 patients have received the drug for longer than 1 year, and about 3,300 patients have received the drug for at least 1.5 years. While the 2 patients who developed PML were on monotherapy, the FDA still believes that natalizumab monotherapy may confer a lower risk of PML than when natalizumab is used together with other immunomodulatory medications. The FDA is working with the manufacturer to amend the product labelling to inform prescribers and patients that cases of PML have occurred in patients taking natalizumab as monotherapy. Recommendations and information for healthcare professionals registered with the TOUCH Prescribing Program to consider when prescribing natalizumab: · The 2 new cases of PML are notable for being the first cases occurring in the absence of concomitant or recent immunomodulatory therapy. · Although PML and other opportunistic infections are known risks of natalizumab, these are the first cases of PML that have been reported following natalizumab's market re-introduction in June 2006. · PML is a rare infection of the central nervous system caused by a virus that can affect patients who have a compromised immune system. · Both of the recently diagnosed patients were receiving natalizumab as monotherapy (1 for 14 months and 1 for 17 months), although 1 of the patients had a history of prior immunosuppressant therapy with azathioprine and beta-interferons. · Both patients were diagnosed on the basis of physical findings, magnetic resonance imaging (MRI) findings, and the detection of JC viral DNA in the cerebrospinal fluid. · The incidence of PML with natalizumab remains unknown, although the available data indicate that the risk of PML when natalizumab is taken as monotherapy is lower than the risk of PML when natalizumab is taken with other immunosuppressant MS treatments. · Continued clinical vigilance and close monitoring for the signs and symptoms of PML as dictated by the TOUCH Prescribing Program is necessary. · Natalizumab should not be infused if PML is suspected. For more information on the 2 cases, please see: http://www.fda.gov/cder/drug/InfoSheets/HCP/natalizumab2008HCP.htm Report serious adverse events to FDA's MedWatch reporting system by completing a form on line at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178), by mail using the postage-paid address form provided online (5600 Fishers Lane, Rockville, MD 20852-9787), or by telephone (1-800-FDA-1088). SOURCE: The US Food and Drug Administration

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