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FDA warns of higher PML risk with increased number of Tysabri infusions
Friday, February 05 2010 | Comments
What's This?
The Food and Drug Administration warned that the risk of progressive multifocal leukoencephalopathy (PML) is greater with Biogen Idec Inc.'s Tysabri (natalizumab) as patients receive more infusions of the drug.The FDA's warning to health care professionals and patients was based on reports of 31 confirmed cases of PML received by the agency as of Jan. 21.
The agency noted that there have been no reports of PML among patients treated with Tysabri for less than one year. Among patients who have received 24 to 36 infusions of the drug, the overall worldwide rate and the U.S. rate of developing PML are similar to that observed during clinical trials, which was one case per 1,000 patients treated. However, outside of the United States, the rate is approximately two cases per 1,000 patients treated. The FDA said the reasons for this difference were not known. The agency added that there is limited experience for more than 36 infusions in either clinical trials or the postmarketing setting.
The label and patient medication guide for Tysabri, which Biogen Idec co-markets with Elan Corp. Plc as a treatment for multiple sclerosis and Crohn's disease, will be updated to include the warning.
The FDA said information about the occurrence of immune reconstitution inflammatory syndrome (IRIS) in patients who discontinued Tysabri after developing PML will also be added to the drug's label. IRIS is a rare condition that is characterized by a severe inflammatory response that can occur during or after immune system recovery, according to the agency. It noted there have been no reports of IRIS in patients who have discontinued Tysabri for reasons other than developing PML.
The FDA believes that the clinical benefits of the drug continue to outweigh the potential risks.
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