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   DIR Return to: GILENYA (fingolimod, FTY720)
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       #Post#: 680--------------------------------------------------
       PML case in MS patient taking Gilenya
       By: agate Date: March 10, 2015, 6:34 pm
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       From the Novartis Website:
       [quote]
       Gilenya Safety Update
       February 16, 2015 17:00 CET
       Novartis confirms that it has received a report of a PML
       (progressive multifocal leukoencephalopathy) case. The patient
       had been receiving Gilenya® (fingolimod) for the treatment of
       relapsing MS (RMS) for more than 4 years.
       The diagnosis was made based on MRI findings and additional
       tests for JC (John Cunningham) virus. The patient is currently
       doing well. The case has been reported to Health Authorities.
       Patient safety is of paramount importance to Novartis, and we
       continue to monitor all aspects of patient safety on an ongoing
       basis. The positive benefit-risk profile of Gilenya in relapsing
       MS is based on experience with 114,000 patients treated with
       Gilenya and more than 195,000 patient years and accumulation of
       real-world efficacy and safety data.[/quote]
       More information is available in a Healthline article (March 9,
       2015):
       [quote]Multiple Sclerosis Patient Taking Novartis’ Gilenya
       Contracts PML
       A woman in a Gilenya after-market study says the company didn’t
       notify all participants about the new case of PML.
       Novartis executives have confirmed a multiple sclerosis (MS)
       patient has developed a rare brain infection after taking their
       drug Gilenya for more than four years.
       The Switzerland-based pharmaceutical company posted a notice on
       their website announcing the development [see above].
       A company spokeswoman said Novartis officials were not available
       to comment on the case.
       The website notice said the patient is doing well. It said the
       patient had been taking Gilenya for an extended period when he
       or she contracted progressive multifocal leukoencephalopathy
       (PML).
       In late October, a patient in Europe died from PML after taking
       Tecfidera for more than four years. Biogen Idec Inc.
       manufactures that MS drug.
       In 2013, the Food and Drug Administration (FDA) sent out an
       alert after a patient in Europe developed PML after taking
       Gilenya for eight months.
       In their web posting, Novartis officials noted Gilenya has a
       “positive benefit-risk profile” in relapsing-remitting MS
       patients based on experience with 114,000 people who have taken
       the drug.
       One woman who is part of a current Gilenya after-market
       extension study said she learned about the most recent PML case
       after Novartis contacted another person in the study. The woman
       then found the announcement on the company’s website.
       Her understanding is that the patient newly diagnosed with PML
       had never taken Tysabri, an older MS drug that has been linked
       to cases of PML in the past.
       The woman in the extension study, who has MS, said she is well
       aware of the remote possibility of contracting PML while taking
       Gilenya, so she wasn’t surprised by the announcement. She was a
       bit miffed, however, that Novartis did not contact everyone in
       her study group or update their informed consent documentation.
       “I’m not upset, but I am disappointed,” the woman said.
       PML is a reactivation of the John Cunningham virus (JCV). JCV
       lives in the bodies of more than 75 percent of people in the
       United States. Most people’s immune systems are strong enough to
       keep the virus at bay.
       People with weakened immune systems are at greater risk. That
       group includes people with AIDS, cancer patients taking
       chemotherapy drugs, transplant patients on anti-rejection drugs,
       and people taking immune-suppressing drugs for autoimmune
       conditions.[/quote]
       This article can be seen here
  HTML http://www.healthline.com/health-news/multiple-sclerosis-patient-taking-novartis-gilenya-contracts-pml-030915.
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