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Nationwide Recall of Remaining Batches of Efalizumab Initiated in Europe LONDON -- June 10, 2009 -- The European Medicines Agency (EMEA) has agreed to an EU-wide recall of all of the remaining batches of efalizumab (Raptiva), from Merck Serono. This means that within the next few days all batches of efalizumab will be recalled from wholesalers, pharmacies, and hospitals. Following this, the medicine will no longer be available anywhere in the European Union. In February 2009, the Agency's Committee for Medicinal Products for Human Use (CHMP) had recommended the suspension of efalizumab's marketing authorisation, because its benefits in the treatment of psoriasis were modest, while there was a risk of serious side effects in patients receiving the medicine, including the occurrence of progressive multifocal leukoencephalopathy (PML). Patients were advised not to stop their treatment abruptly but to switch to alternative treatment gradually. As a condition for lifting the suspension, the CHMP recommended that new evidence should be provided to identify a subgroup of patients for which the benefits of efalizumab would outweigh the risks. However, the Marketing Authorisation Holder informed the CHMP in April 2009 that it did not intend to conduct further clinical trials. In May 2009, Merck Serono formally requested the Marketing Authorisation in the EU to be withdrawn. The European Commission decision is expected to be issued soon. All patients who were treated with efalizumab before the suspension should now have been switched to alternative treatments. The Agency has been working closely with the company to organise the complete recall of all remaining batches of efalizumab in the EU, in accordance with the process agreed in each individual Member State. SOURCE: European Medicines Agency E-mail this page to a friend or colleague! To print, use this version