WHO Drug Information Vol. 23, No. 1, 2009 - World Health ...

WHO Drug Information Vol 23, No. 1, 2009Regulatory Action and NewsEfalizumab: suspension ofmarketing authorizationEuropean Union — The EuropeanMedicines Agency (EMEA) has recommendedsuspension of the marketingauthorization for efalizumab (Raptiva®).The EMEA’s Committee for MedicinalProducts for Human Use (CHMP) hasconcluded that the benefits of efalizumabno longer outweigh its risks because ofsafety concerns, including the occurrenceof progressive multifocal leukoencephalopathy(PML) in patients taking the medicine.Efalizumab has been authorized in theEuropean Union (EU) since September2004 to treat adult patients with moderateto severe chronic plaque psoriasis whohave failed to respond to, or who have acontraindication to, or are intolerant ofother systemic therapies includingciclosporin, methotrexate and PUVA(psoralen ultraviolet–A).The CHMP carried out the review followingreports of serious side effects, includingthree confirmed cases of PML inpatients who had taken efalizumab formore than three years. PML is a rarebrain infection that usually leads tosevere disability or death. Two of thethree confirmed cases of PML reported tothe CHMP resulted in the patient’s death.The CHMP also received an additionalreport of a suspected case of PML whichcould not be confirmed.Following review of all available data onthe medicine’s safety and effectiveness,the CHMP concluded that:• Efalizumab’s benefits are modest.• In addition to PML, efalizumab is associatedwith other serious side effects,including Guillain-Barré and Miller-Fisher syndromes, encephalitis, encephalopathy,meningitis, sepsis andopportunistic infections.• There is not enough evidence to identifya group of patients in which the benefitsof efalizumab outweigh its risks, inparticular there is a lack of data oneffectiveness and safety in patients whohave no other treatment options andwho may already have a weakenedimmune system as result of previoustreatments.The CHMP was therefore of the opinionthat the risks of efalizumab outweigh itsbenefits and that the marketing authorizationfor this medicine should be suspendedin the EU.Prescribers should not issue any newprescriptions for efalizumab and shouldreview treatment of patients currentlyreceiving the medicine to assess the mostappropriate alternatives. They shouldmake sure that patients who have beentreated with efalizumab are closelymonitored for neurological symptoms andsymptoms of infection. Patients who arecurrently taking efalizumab should notstop treatment abruptly, but should makean appointment with their doctor todiscuss the most appropriate replacementtreatment.Reference: Press Release, Doc. Ref. EMEA/CHMP/20857/2009 dated 19 February 2009.http://www.emea.europa.eu35