Changes after publication
The European Medicines Agency (EMEA), the European Union (EU) body which is responsible for monitoring the safety of medicines, has withdrawn the marketing authorisation for MerckSerono's psoriasis drug efalizumab (Raptiva).
The EMEA's Committee for Medicinal Products for Human Use has reviewed possible links between the drug and a rare but deadly brain infection and said the benefits of efalizumab no longer outweigh its risks, because of safety concerns, notably the occurrence of progressive multifocal leukoencephalopathy. As a result the 'British national formulary' has been updated to say that efalizumab should not be prescribed for patients who are not already taking it. Treatment for patients who are taking efalizumab should be reviewed.
Therefore, NICE has withdrawn its guidance on the use of efalizumab for the treatment of adults with psoriasis. Guidance on the use of etanercept for the treatment of adults with psoriasis remains the same and in force.
Further information on the EMEA's decision is available from the EMEA website.
March 2014: minor maintenance
March 2012: minor maintenance