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FDA Continues to Receive Reports of PML in Patients Receiving Natalizumab ROCKVILLE, Md -- September 22, 2009 -- The US Food and Drug Administration (FDA) continues to receive reports of progressive multifocal leukoencephalopathy (PML) in patients receiving natalizumab (Tysabri). Natalizumab was approved by the FDA for the treatment of relapsing forms of multiple sclerosis (MS) in November 2004 and for moderately to severely active Crohn’s disease in January 2008. From July 2006, (when Tysabri marketing resumed) to September 8, 2009, 13 reported cases of natalizumab-related PML were confirmed worldwide in patients being treated for MS with natalizumab monotherapy. Of these, 4 cases were patients in the United States. There have been no postmarketing reports of PML in patients treated with natalizumab for Crohn’s disease. The risk for developing PML appears to increase with the number of natalizumab infusions received. The number of monthly infusions of natalizumab in the 13 patients who developed PML ranged from 12 to 35 infusions. The average number of infusions received before the diagnosis of PML was 25. There is minimal experience in patients who have received more than 35 infusions of natalizumab. The overall rate of developing PML with natalizumab therapy in patients who have received at least 1 infusion remains below 1 per 1,000 patients. Based on available data from the US and outside of the US, the current rate of PML in patients who have received at least 24 infusions ranges from 0.4 to 1.3 per 1,000 patients. At this time, the FDA is not requiring changes regarding PML to the natalizumab prescribing information or to the natalizumab risk management plan, called the TOUCH Prescribing Program. All patients receiving natalizumab therapy in the US must be enrolled in the TOUCH Prescribing Program. Under this program, every patient who receives natalizumab is closely monitored for the occurrence of PML and other serious opportunistic infections. To report any serious adverse events associated with the use of this drug, please contact the FDA MedWatch program. SOURCE: US Food and Drug Administration E-mail this page to a friend or colleague! To print, use this version