10th PML Case Confirmed by Biogen

Biogen Idec Inc. has reported a new case of a potentially lethal brain inflammation in a patient using its drug Tysabri, the tenth such case since the [...]

• Caroline says: This is the 3rd case in the last couple of weeks, all are in people who have received around 30 infusions (Biogen says PML shows up on average after 24 months)...I think there is going to be a Tysabri-holiday mandated after 24 months because this seems like an awful lot of PML.
   

• Tysabri Side Effects Linked to 9th PML Infection Case

  A new case of a rare, often lethal, brain infection has been linked to the multiple sclerosis drug Tysabri, making it the ninth case of progressive multifocal [...]

  • Caroline says: Yikes...This is the second Tysabri-induced PML infection I've read about in a week. This article is quick to point out that this particular patient lives outside of the US (so perhaps there are less stringent monitoring requirements when it is prescribed?) and developed PML after his 34th infusion.
     
  
  

  • Biogen Says Eighth Patient Has Infection From Tysabri

    By Tom Randall June 12 (Bloomberg) — Biogen Idec said a patient taking its multiple sclerosis drug Tysabri was diagnosed with a life-threatening brain illness, the eighth [...]

    • Caroline says: Biogen confirms the 8th case of PML in the last year with a pt taking Tysabri. No real information on the pt was revealed in this article, such as pt's age, time on Tysabri, etc. Best of luck to them, however.
       
    
    

    • Hot off the AAN Press: Fingolimod effective but safety an issue

      UPDATE 3-Novartis MS drug effective but safety an issue ZURICH, April 29 (Reuters) – Novartis AG  said 80-83 percent of those taking its multiple sclerosis drug FTY720 [...]

      • Caroline says: Novartis presented Phase III results showing an annual relapse rate of 52% lower than Biogen's Avonex. That's significant. Safety issues abound with fingolimod though, but as we saw with Tysabri, many patients choose to accept these risks if it means more control of their disease.
         
      
      

      • Hot off the AAN Press: Tysabri May Reverse MS Damage

        UPDATE 1-Elan’s Tysabri may reverse MS damage, shares up April 29 (Reuters) – Elan’s  Tysabri drug may be able to reverse damage caused by multiple sclerosis, the [...]

        • Caroline says: Data presented at this year's AAN showed Tysabri promoted the regeneration of the protein coat that protects nerve fibres and whose damage causes the symptoms of MS. This is good news, Tysabri has done wonders for so many people. It didn't work so well for me and I was on it for just a few months before a new lesion broke through.
           
        
        

        • Biogen Idec announces sixth case of PML linked to use of Tysabri

          Biogen Idec reported that another patient with multiple sclerosis taking Tysabri (natalizumab) was diagnosed with progressive multifocal leukoencephalopathy (PML) earlier this month, raising the total number of [...]

          • Caroline says: Yikes...more evidence for the Tysabri holiday people have been pushing...best of luck to this patient.
             
          
          

          • Biogen Receives FDA Warning for Tysabri (re Internet Ads)

            FDA Warns Drug Firms Over Internet Ads WASHINGTON — The Food and Drug Administration warned 14 major pharmaceutical companies about brief Internet ads that accompany searches on [...]

            • Caroline says: Tsk, tsk, Biogen. They got a letter from the FDA regarding internet ads for Tysabri and the fact that they do not discuss any of the risks of Tysabri.
               
            
            

            • Biogen hopes to have PML-related test by year-end

              By Toni Clarke BOSTON (Reuters) – Biogen Idec Inc said on Wednesday it is developing a test that can identify the presence of a virus that can [...]

              • Caroline says: This is interesting. For people taking Tysabri now, intensive monitoring and frequent (read: painful) spinal taps are often needed. According to this article, MS drug making giant Biogen (maker of Tysabri) is developing a test to determine whether a candidate for Tysabri has the JC virus (precursor to PML) in their blood.
                 
              
              

              • Malaria Pill=The End of PML?

                Elan shares soar on news of possible Tysabri side-effect treatment SHARES IN drug company Elan bounced more than 10 per cent yesterday after news emerged of a [...]

                • Caroline says: Tysabri (Biogen) is a terrific drug that has helped a LOT of people. However, even after its re-emergence into the market in July 2006, Biogen reported 5 new cases of PML in PWMS taking Tysabri. PML is nearly 100% fatal, so this isn't a trivial matter. Today, there's news that Biogen/Elan are testing a malaria pill developed during the Vitenam War as a potential treatment for PML.
                   
                
                
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