Does Gilenya Cause PML?

PML, Progressive Multifocal Leukoencephalopathy, a rare and sometimes fatal brain infection who’s symptoms are similar to Multiple Sclerosis, has always been synonymous with Tysabri (Natalizumab) but last Tuesday a case of PML was reported by a patient taking Novartis’ Gienya (Fingolimod). Gilenya is an oral DMD (Disease Modifying Drug) that was approved by the FDA in 2010 with the most common side effects being no more severe than headache, influenza, diarrhea, back pain, abnormal liver tests, and cough but now will we see PML be added to the list?

Tysabri, the once a month, intravenous (IV) DMD, that is most commonly known to be the “DMD that causes PML”, was approved in 2004 and temporarily taken off the market in 2005 because of 3 cases of PML that had come up. 1 year is much quicker than the 3 years it took to see PML in Gilenya so most likely PML will remain to be much more rare in Gilenya than it is in Tysabri but a risk is a risk and if Gilenya really does turn out to be the cause of this case of PML what will that mean for the FDA’s approval of Gilenya? Will this warrant a warning label change? Perhaps the risk associated with PML and Gilenya just takes longer to present than it does in Tysabri? That makes me wonder, will we be seeing more cases of Gilenya related PML start popping up?

“By the time there was a similar level of patient experience with
Tysabri there had been 298 cases reported. Thus, even if the risk proves
to be real it is likely to be of a very different order of magnitude,”
-Deutsche bank analyst Tim Race

6 thoughts on “Does Gilenya Cause PML?

  • August 15, 2013 at 6:25 pm
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    I am betting the person had the JC virus I had never even heard of it until the Neuro wanted to put me on Tysabri and said that I had to be tested for the JC virus because if you have that virus then you cannot take Tysabri because of the PML risk.

    I did research on the JC virus because I tested positive and learned that really the only way to get PML is to have the JC virus which is believed to be postive in as low as 40% of the population to as high as 90%.

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  • August 15, 2013 at 6:43 pm
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    Well, yeah, you have to have JC to get PML but you can get it any time, its common, most people with or without MS have it but you just never know about it. If you are JC positive you CAN still get Tysabri you are just more at risk of PML. But bottom line is, the drug still has to CAUSE it to give it to you you know?

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  • August 28, 2013 at 10:24 pm
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    I have had MS since I was 15 (2004) and I am 24 now. Started having issues in 2010….(walking) I had been on Rebif until March of this year. The neuro wants to change my medicine. I decided to go with Gilenya. I have not yet started (eye exams, blood work ) Now it's time to set the appt. for the first dose. Now I am hearing about PML cases with the Gilenya. So needless to say I'm quite nervous about starting.I don't know what to think or what I should do?

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  • August 28, 2013 at 10:28 pm
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    I am not sure what advice to give. PML doesnt scare me all that much because they test for it very often, they watch you closely so your safe. But since they don't do that for Gilenya or Tecfidera because they don't think it is an actual risk, it becomes more of a risk because if it IS coming you can't SEE it coming! I am sure most doctors would say you are fine but idk, I like to know for sure the risks… I mean there is always Aubagio, oral medication, so far no risks like PML haha….

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  • August 28, 2013 at 11:41 pm
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    I hear ya … I know they do MRI's when your on the Tysabri …as far as the Gilenya I don't think they monitor you that way…. I never heard of Aubagio..I will have to check more into that. Thanks again

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  • August 28, 2013 at 11:53 pm
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    Yeah they only do it for Tysabri, I am due for an MRI and another spinal tap I think. But yeah look into it!

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