Please note: On the 19 February 2009 The European Medicine Agency Committee for Medicinal Products for Human Use (CHMP) has recommended the suspension of the marketing authorisation for Raptiva (efalizumab), from Serono. CHMP has concluded that the benefits of Raptiva no longer outweigh its risks, because of safety concerns, including the occurrence of progressive multifocal leukoencephalopathy (PML) in patients taking the medicine.

Click here for full EMEA press release.


UPDATE 8 June 2009

EU-wide recall of Raptiva (efalizumab) to be initiated. The European Medicines Agency has agreed to an EU-wide recall of all of the remaining batches of Raptiva, from Merck Serono. This means that within the next few days all batches of Raptiva will be recalled from wholesalers, pharmacies and hospitals. Following this, the medicine will no longer be available anywhere in the European Union.

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 Raptiva 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 In May 2009, Merck Serono formally requested the Marketing Authorisation in the EU to be withdrawn.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 Raptiva 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 Raptiva in the EU, in accordance with the process agreed in each individual Member State.

Click here for full EMEA press release.


Content review dates