Author Topic: PML case in MS patient taking Gilenya  (Read 151 times)

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Offline agate

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PML case in MS patient taking Gilenya
« on: March 10, 2015, 02:34:07 pm »
From the Novartis Website:

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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.

http://www.novartis.com/newsroom/product-related-info-center/gilenya-safety-update.shtml

More information is available in a Healthline article (March 9, 2015):

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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.

This article can be seen here.
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