Raptiva ® (efaluzimab) is approved in Europe since September 2004. It is indicated for the treatment of plaque psoriasis in patients who do not respond or are intolerant to other treatments which are cons-indicated. The occurrence of 3 cases of progressive multifocal leukoencephalopathy (PML), led the European Agency for the Evaluation of Medicinal Products (EMEA) to recommend suspension of the authorization to market Raptiva ®. The occurrence since September 2008 to 3 cases of progressive multifocal leukoencephalopathy (PML), led the European Agency for the Evaluation of Medicinal Products (EMEA) to recommend the suspension of the authorization to market Raptiva ®. PML is a rare brain infection and death. It infects the brain cells (oligodendrocytes) that produce the protective coating (myelin) of nerve cells.
To date and in France, an estimated 560 patients are being treated.
Afssaps recommends that prescribers not to introduce Raptiva ® and monitor the occurrence of neurological symptoms and infections among patients treated with Raptiva ® during a period of 8 to 12 weeks after stopping treatment.
Patients should not abruptly stop Raptiva ®. They should consult their prescribing physician to rapidly implement the alternative treatment is best.
In addition, Afssaps consults with agencies of other European countries concerned, the laboratory and trial sponsors to take appropriate measures regarding ongoing clinical trials. Patients in these trials are invited to contact the doctor who conducted the test to obtain information and define the therapeutic holding.
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