FDA warns of cases of deadly brain infection linked to Raptiva; EMEA urges suspension
The US Food and Drug Administration has issued a public health warning on biotechnology giant Genentech's Raptiva (efalizumab) after it received reports of three confirmed and one possible case of a serious brain infection in patients on the psoriasis drug.
Meanwhile, the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has recommended suspending the drug's marketing authorization in the European Union.
Progressive multifocal leukoencephalopathy is a rare and usually fatal viral disease that has been linked to several immunosuppressive drugs, including most recently multiple sclerosis drug Tysabri (natalizumab; Marketletters passim).
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