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   DIR Return to: TYSABRI (natalizumab)
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       #Post#: 1104--------------------------------------------------
       New European Medicines Agency (EMA) advice to cut PML risk w/Tys
       abri in MS
       By: agate Date: February 12, 2016, 8:02 pm
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       Medscape news alert, February 12, 2016:
       [quote]New EMA Advice to Reduce PML Risk With Natalizumab
       (Tysabri) in MS
       Susan Jeffrey
       The European Medicines Agency (EMA) today released new
       recommendations aimed to reduce the risk for progressive
       multifocal leukoencephalopathy (PML) with use of natalizumab
       (Tysabri, Biogen) in patients with relapsing remitting multiple
       sclerosis (MS).
       The recommendations come from a review of PML risk associated
       with natalizumab begun in May 2015 by the EMA's
       Pharmacovigilance Risk Assessment Committee (PRAC) with the aim
       of minimizing that risk.
       "Recent studies suggest that early detection and treatment of
       PML when the disease is asymptomatic (is still in the initial
       stages and shows no symptoms) are critically important in
       limiting the degree of brain damage and resulting disability
       caused by the disease," an EMA statement released today notes.
       "Asymptomatic cases of PML can be detected on [a magnetic
       resonance imaging] scan. On the basis of this data, the PRAC
       concluded that for patients at higher risk of PML, more frequent
       [magnetic resonance imaging] scans (e.g. every 3 to 6 months)
       should be considered."
       Known risk factors for the development of PML in patients
       treated with natalizumab are the presence of antibodies against
       John Cunningham (JC) virus, treatment with natalizumab for more
       than 2 years, and treatment with immunosuppressant drugs before
       starting treatment with natalizumab. Patients who have all three
       risk factors are considered at higher risk for PML, the
       statement notes.
       New data from clinical studies suggest that in patients who have
       not been treated with immunosuppressants before starting
       natalizumab, the JC virus antibody index relates to the level of
       risk for PML, the EMA writes.
       "More specifically, current evidence suggests that the risk of
       PML is small, and lower than previously estimated, at antibody
       index values of 0.9 or less, and increases substantially in
       patients with index values above 1.5 who have been treated with
       Tysabri for longer than 2 years," the EMA statement notes.
       "Therefore, the PRAC concluded that patients with a high
       antibody index who have not used immunosuppressants before
       Tysabri and have been treated with Tysabri for more than 2 years
       are also considered at higher risk of PML."
       In patients at higher risk of developing PML, treatment with
       natalizumab should [be continued only] if the benefits outweigh
       the risks, it adds.
       For those patients with a low antibody index who have not used
       immunosuppressant drugs before starting natalizumab, the PRAC
       recommends repeating the antibody test every 6 months, once they
       have been receiving natalizumab for longer than 2 years.
       In patients who test negative for JC antibodies, the antibody
       test should be repeated every 6 months, the committee
       recommends. "If PML is suspected at any time, treatment with
       Tysabri must be stopped until PML has been excluded," the EMA
       statement notes.
       The PRAC recommendation will now be forwarded to the Committee
       for Medicinal Products for Human Use for the adoption of EMA
       final opinion. Further details including advice for patients and
       healthcare professionals will be published at the time of the
       committee's opinion, the statement concludes.
       The final stage of the review procedure is the adoption by the
       European Commission of a legally binding decision applicable in
       all EU Member States.
       In December 2015, the EMA issued advice on minimizing the risk
       for PML and basal cell carcinoma in patients taking fingolimod
       (Gilenya, Novartis), and in October 2015, recommendations for
       reducing PML risk with dimethyl fumarate (Tecfidera, Biogen) in
       patients with MS.[/quote]
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