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Evidence-Based Dermatology: Research Commentary
September 2009

The Misperception That Clinical Trial Data Reflect Long-term Drug Safety: Lessons Learned From Efalizumab's Withdrawal

Author Affiliations

Copyright 2009 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2009

Arch Dermatol. 2009;145(9):1037-1039. doi:10.1001/archdermatol.2009.188

Commentary on: Press Release: European Medicines Agency recommends suspension of the marketing authorisation of Raptiva (efalizumab).

The European Medicines Agency


The European Medicines Agency (EMEA) has recommended the suspension of the marketing authorisation for Raptiva (efalizumab), from Serono. The EMEA's Committee for Medicinal Products for Human Use (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.1