Raptiva marketing authorisation suspended

The European Medicines Agency (EMEA) has recommended that the marketing authorisation for Raptiva be suspended across Europe following a review by its Committee for Medicinal Products for Human Use (CHMP) which concluded that the benefits of Raptiva no longer outweigh its risks.

The CHMP reviewed Raptiva after receiving reports of serious side effects including three confirmed cases of progressive multifocal leukoencephalopathy (PML) in patients who had been receiving Raptiva for more than three years, two of which were fatal. The CHMP reviewed information that had become available through post-marketing experience and ongoing clinical trials. As it was not possible to determine which patients are more susceptible to developing PML it was decided that introducing restrictions on those able to receive the drug would not be appropriate.

Prescribers should not issue any prescriptions for Raptiva to patients not already receiving it and should review the treatment of all patients currently taking the medicine with a view to stopping it. However, treatment should not be stopped abruptly as this could result in the psoriasis returning or worsening. Alternative treatments should be considered and the patient's condition should be monitored. Patients should be closely monitored for infections and neurological symptoms after they have ceased treatment as the effects of efalizumab can last for about eight to 12 weeks.

Further information: EMEA Q&A on Raptiva suspension

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