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       #Post#: 1040--------------------------------------------------
       New EMA advice for PML prevention with fingolimod in MS
       By: agate Date: December 19, 2015, 9:44 pm
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       EMA = European Medicines Agency. It has been in existence for 20
       years and monitors medicines used throughout the European Union.
       From Medscape, December 18, 2015:
       [quote]New EMA Advice for PML Prevention With Fingolimod in MS
       Pauline Anderson
       Patients with multiple sclerosis (MS) should be evaluated
       before, and regularly during, treatment with fingolimod
       (Gilenya, Novartis) to identify signs and symptoms possibly
       linked to progressive multifocal leukoencephalopathy (PML) or
       basal cell carcinoma (BCC), according to new recommendations
       issued by the European Medicines Agency (EMA) with the aim of
       minimizing PML risk with treatment.
       Before starting fingolimod, physicians should obtain a baseline
       MRI scan as a reference, said the EMA in a statement released
       today. During routine MRI, they should pay attention to lesions
       suggestive of PML.
       If PML is suspected, MRI should be performed immediately and
       treatment with fingolimod should be suspended until PML has been
       excluded, said the agency.
       PML, a rare brain infection linked to the JC virus, causes
       symptoms that may be similar to those of an MS attack and may
       result in severe disability or death. Symptoms may include
       changes in mood or behavior, memory lapses, and speech and
       communication difficulties.
       Fingolimod reduces the activity of the immune system, in
       particular of T cells. For this reason, patients treated with
       this medication may be at higher risk for infections and
       diseases, including PML and certain cancers.
       PML is more likely to occur during treatment with fingolimod if
       patients were previously treated with natalizumab (Tysabri,
       Biogen), another MS drug that suppresses the immune system.
       However, three recent confirmed cases of PML were reported in
       patients taking fingolimod who had not been treated with
       natalizumab.
       The EMA urged doctors to be alert about the risk for PML with
       fingolimod and to inform patients and caregivers of early signs
       and symptoms suggestive of PML. They should tell patients to
       seek medical advice if they think their disease is getting worse
       or if they notice any new or unusual symptoms.
       PML can occur only in the presence of JC virus infection. The
       EMA noted that the influence of lymphopenia on the accuracy of
       the anti-JC virus antibody test has not been studied in patients
       treated with fingolimod. Doctors should also note that a
       negative antibody test result does not preclude the possibility
       of subsequent JC virus infection, said the agency.
       Patients taking fingolimod may also be at higher risk for BCC.
       Although BCC is a slow-growing skin cancer that almost never
       spreads to other parts of the body or becomes life-threatening,
       it can be disfiguring if not treated promptly.
       Some 151 cases of this cancer have been reported in patients
       taking fingolimod. The agency stressed fingolimod must not be
       used in patients with BCC or any other type of cancer.
       The EMA recommends an evaluation of the skin to look for sores,
       lumps, or lesions that might be a sign of cancer before starting
       treatment with fingolimod. This examination should then be
       repeated once a year during treatment with this drug.
       Fingolimod isn't the only oral MS drug linked to PML. To date,
       four cases have been tied to the use of dimethyl fumarate
       (Tecfidera, Biogen). Tecfidera, an oral agent taken twice daily,
       has been available for the treatment of MS since 2013. The
       generic compound, dimethyl fumarate, and similar products
       containing fumaric acid esters have long been used to treat
       psoriasis.
       As well as the four cases of PML in patients with MS, about 10
       cases in patients with psoriasis have reportedly been linked to
       such products.
       [/quote]
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