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       #Post#: 903--------------------------------------------------
       3rd PML case with Gilenya in MS
       By: agate Date: August 18, 2015, 6:52 pm
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       From Medscape, August 18, 2015:
       [quote]Third Case of PML With Fingolimod (Gilenya) in MS
       Megan Brooks
       Freelance writer, Medscape
       Disclosure: Megan Brooks has disclosed no relevant financial
       relationships.
       Novartis has been notified of a third case of progressive
       multifocal leukoencephalopathy (PML) in a patient with relapsing
       multiple sclerosis (MS) treated with fingolimod (Gilenya).
       According to an August 17 notice on the company's Gilenya
       Information Center Web page, the diagnosis of PML was based on
       suggestive clinical symptoms, magnetic resonance imaging
       findings, and tests for JC virus. The patient did not have prior
       exposure to natalizumab (Tysabri, Biogen) treatment, which is
       already associated with increased PML risk.
       The patient has a history of colorectal cancer treated with
       chemotherapy and radiation treatment, as well as Crohn's
       disease, and Novartis says they are currently in "active
       discussions with external advisors to review details of this
       case and the role of various risk factors contributing to the
       development of PML."
       Earlier this month, the US Food and Drug Administration (FDA)
       warned that a case of definite PML and a case of probable PML
       have been seen in patients taking fingolimod for relapsing MS,
       as reported by Medscape Medical News. Neither of these patients
       had previously received natalizumab treatment.
       The first case was a 49-year-old who developed probable PML
       after taking fingolimod for approximately 4 years. The patient
       had a 5-year history of MS and had previously been treated for
       relapse with interferon beta-1a (Rebif) for 10 months in
       addition to short-term corticosteroids before and during
       fingolimod treatment.
       The second case was a 54-year-old who developed PML after taking
       fingolimod for approximately 2.5 years. The patient had a 13- to
       14-year history of MS and had previously been treated with
       interferon beta-1b for approximately 11 years, as well as with
       mesalazine for ulcerative colitis for the last 4 years.
       ....
       In the August 17 notice, Novartis says with more than 125,000
       patients have been treated with fingolimod and 240,000 patient
       years of exposure in both clinical trials and postmarketing
       setting, they continue to "stand behind the positive
       benefit-risk profile" of the drug in relapsing MS.
       [/quote]
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