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Manufacturer of Efalizumab Announces Voluntary Withdrawal From US Market NEW YORK -- April 8, 2009 -- Genentech, Inc. announced today a phased voluntary withdrawal of efalizumab (Raptiva) from the US market. The company's actions have been taken after consultation with the US Food and Drug Administration (FDA) and are based on the association of efalizumab with an increased risk of progressive multifocal leukoencephalopathy (PML). Efalizumab is indicated for the treatment of chronic moderate-to-severe plaque psoriasis in adults aged 18 years or older who are candidates for systemic therapy or phototherapy. Effective immediately, physicians should not issue prescriptions for efalizumab for any new patients and should promptly contact patients currently receiving efalizumab to assess the most appropriate treatment alternatives. Efalizumab will no longer be available after June 8, 2009. This transition period is intended to allow patients, who are currently taking efalizumab enough time to work with their doctors to appropriately discontinue use of the drug. The prescribing information for efalizumab was updated in October 2008 to include a boxed warning on the risk of serious infections, including PML. The prescribing information was further updated in March 2009 to include additional information on the risk of PML and a new Medication Guide for patients. There have been 3 cases of diagnosed PML in patients receiving efalizumab and 1 patient who developed progressive neurologic symptoms and died of unknown cause. It is not known whether other, unreported cases have occurred. The company has taken immediate steps to inform potential prescribers, patients, clinical trial investigators, and distributors of the decision to withdraw efalizumab from the market in the US. Genentech is working with Merck Serono, its licensee outside the US and Japan to inform regulatory authorities outside of the US of Genentech's decision to withdraw efalizumab from the US market. Physicians with questions about Raptiva use may contact Genentech Medical Communications at 1-800-821-8590. SOURCE: Genentech E-mail this page to a friend or colleague! To print, use this version