FDA and EMEA, the two main regulatory agencies on medicines and medical devices, today posted relevant prescription information about Raptiva (efalizumab), following reports of progressive multifocal leukoencephalopathy (PML). Raptiva is a recombinant humanized monoclonal antibody for the treatment of plaque psoriasis.

EMEA has made clear their verdict: they recommend suspension of the marketing authorization of Raptiva (efalizumab). The CHMP concluded :

They recommend that:

Prescribers should not issue any new prescriptions for Raptiva and should review the treatment of patients currently receiving the medicine to assess  the most appropriate alternatives. They should make sure that patients who have been treated with Raptiva are closely monitored for neurological symptoms and symptoms of infection. Patients  who are currently taking Raptiva should not stop treatment abruptly, but should make an appointment with their doctor to discuss the most appropriate replacement treatment.

On the other hand, the FDA issued the following public health advisory with recommendations for prescribers :

You can also check the letter from EMD Serono Canada Inc to health care professionals

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