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| |  EMEA Recommends Suspension of Efalizumab, FDA Continues Its Safety Review NEW YORK -- February 19, 2009 -- The European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of efalizumab (Raptiva) no longer outweigh its risks, because of safety concerns and has recommended to the European Commission that the marketing authorisation for efalizumab be suspended. In a separate press release issued today by the US Food and Drug Administration (FDA), the agency has informed healthcare professionals that it is reviewing all relevant information regarding the safety of the drug to ensure that its risks do not outweigh its benefits. Since the approval of efalizumab in October 2003, the FDA and the EMEA have received reports of 3 confirmed cases and 1 possible case of progressive multifocal leucoencephalopathy (PML) in patients aged 47 to 73 years who were using efalizumab for the treatment of moderate to severe plaque psoriasis. Two of the patients with confirmed PML and 1 patient with possible PML died. All 4 patients were treated with efalizumab continuously for more than 3 years. None of the patients were receiving other treatments that suppress the immune system while taking efalizumab. Following the review of all available data on the medicine's safety and effectiveness, the CHMP concluded that efalizumab's benefits are only modest. In addition to PML, efalizumab is associated with other serious side effects, including Guillain-Barré and Miller-Fisher syndromes, encephalitis, encephalopathy, meningitis, sepsis, and opportunistic infections. The CHMP does not believe there is enough evidence to identify a group of patients in which the benefits of efalizumab outweigh its risks; in particular there is a lack of data on effectiveness and safety in patients who have no other treatment options and who may already have a weakened immune system as result of previous treatments. The CHMP has therefore recommended that the marketing authorisation for this medicine should be suspended in the European Union. The EMEA's recommendation has been sent to the European Commission for the adoption of a legally binding decision. Prescribers in the European Union should not issue any new prescriptions for efalizumab and should review the treatment of patients currently receiving the medicine to assess the most appropriate alternatives. They should make sure that patients who have been treated with efalizumab are closely monitored for neurological symptoms and symptoms of infection. The FDA is reviewing this latest information and will take appropriate steps to ensure that the risks of efalizumab do not outweigh its benefits and that patients prescribed efalizumab are clearly informed of the signs and symptoms of PML. The FDA asks healthcare providers and patients to report possible cases of PML to the FDA through the MedWatch program by phone (1-800-FDA-1088) or by the Internet at http://www.fda.gov/medwatch/index.html. SOURCE: European Medicines Agency and US Food and Drug Administration
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