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 :
- Raptiva’s benefits are modest;
- in addition to PML, Raptiva is associated with other serious side effects, including Guillain-Barré and Miller-Fisher syndromes, encephalitis, encephalopathy, meningitis, sepsis and opportunistic infections (infections occurring in people with compromised immune systems);
- there is not enough evidence to identify a group of patients in which the benefits of Raptiva outweigh its risks, in particular there is a lack of data on effectiveness and safety in patients who have no other treatment options and who may already have a weakened immune system as result of previous treatments.
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 :
- Raptiva increases the risk of PML. Longer, continuous use may further increase this risk.
- Inform patients using Raptiva of the potential risk of developing PML.
- There are no known screening tests that can reliably predict PML or medical interventions that can prevent or treat this disease.
- Monitor patients being treated with Raptiva for the onset of neurologic symptoms. Discontinue Raptiva if PML is suspected.
- Patients treated with Raptiva should be periodically re-evaluated to ensure that the benefit of treatment continues to outweigh the risks. Consideration should be given to use of other approved therapies to control the patients’ psoriasis.
- The effects of periodic or intermittent use of Raptiva, or the concomitant use of other immunosuppressant drugs on the risk for PML is not known.
You can also check the letter from EMD Serono Canada Inc to health care professionals