Wednesday, 31 July 2013

First case of PML that may be attributable to fingolimod

#MS Research # MSBlog PML after Gilenya

Reuters: Patient taking Novartis MS pill developed rare disease. Tue Jul 30, 2013 2:48pm IST

... A patient taking Novartis' multiple sclerosis pill Gilenya developed a rare and potentially fatal viral disease, the Swiss drugmaker said on Tuesday, an unexpected setback as it faces growing competition from new oral treatments....

.... Novartis said it had been informed of a case of progressive multifocal leukoencephalopathy (PML) in a patient who had been taking Gilenya for MS for seven months....

.... It said it was working with the reporting physician to understand all possible contributing factors, including those beyond treatment, given several atypical features of the case....

.... "The course of the underlying neurological disease was rapid with some atypical findings for MS on the MRI scans of the brain and spinal cord, as well as some unusual clinical features," Novartis said in a statement....

.... Novartis said all previously reported cases of PML among the approximately 71,000 patients treated with Gilenya thus far had been attributed to prior treatment with Biogen Idec's Tysabri, which bears a known risk of PML....

Click here for full article


  1. Can't say I'm entirely surprised. Incidence much lower than with Tysabri though.

  2. SPMSer on blind drug trial for Tysabri, positive for JC virus. Trying to do the right thing!

  3. Hope PML doesnt rear its ugly head with regards to BG-12. Wish the article had given us more info on the patient. Age? Other medicines or illness's etc...I wasnt really concerned with the market/trading details of stock for novartis at the moment

      Guest post: FUMADERM and PML – can we make conclus...
      23 Jan 2013
      "In response to the intense interest on the blog concerning Fumaderm and PML and its possible implications for BG12, we invited Professor Doctor Ralf Gold to contribute a guest post on this topic! I hope it answers some of ...
      Multiple Sclerosis Research: PML and fumarates
      20 Jan 2013
      In response to the queries regarding BG12, fumarates and PML. Yes, there .... I would however frame my answer is a specific way: "PML as a complication of BG-12 therapy is a potential risk that is currently undefined. The risk ...

  4. Have Novartis released any data on how many patients have got PML whilst taking Gilenya,whether Tysabri naive or not?

    1. G may know i know of other cases that i think have been mentioned on blog but these people were tysabrians

    2. I know of one post Natalizumab and now this case.

    3. Wasn't it the cas occured 3yrs 1/2 after natalizumab's withdrawal? could it be in that cas inputaded to natalizumab?


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