FDA details timeframe of Tysabri’s PML risk

The brain infection risk from Biogen Idec’s multiple sclerosis drug Tysabri appears highest during the third year of treatment, U.S. health officials said in an updated warning [...]

• Caroline says: Biogen's billion-dollar drug Tysabri has been a miracle drug for many, many MS patients -- but it has not been without risk of developing PML, a potentially deadly brain infection. The FDA has now released a timeline of when patients are most likely to develop PML -- the risk is highest in year 3 of treatment. Tysabri's label was recently updated in the US to include the risk of PML.
   

• Related Links:
• http://www.reuters.com/article/2011/04/22/us-biogen-tysabri-idUSTRE73L2WN2011042…

• Biogen Reports 2 New PML Cases in October

  The Cambridge, Massachusetts-based biotechnology company said in its latest monthly update that as of Oct. 1, there have been 70 confirmed cases of PML, up from 68 [...]

  • Caroline says: This brings the total number of cases to 70, 14 of them fatal. I just read that the test Biogen has developed to assess PML risk could be available as early as January 2011.
     
  • Related Links:
  • http://newsgroups.derkeiler.com/Archive/Alt/alt.support.mult-sclerosis/2010-10/m…
  
  

  • Five more cases of PML linked to Tysabri

    Biogen has reported five more cases of rare brain infection PML in patients taking Tysabari, the multiple sclerosis drug it jointly sells with Irish based Elan. This [...]

    • Caroline says: Biogen is reporting another 5 cases of Tysabri-induced PML No information is given on country of origin -- and if I had to guess I would assume the US probably has the fewest cases because of the mandatory TOUCH prescribing program. According to this article, 52,000 patients are currently taking Tysabri and the MS Society estimates that 2.5 million people worldwide have MS.
       
    • Related Links:
    • http://www.businessandfinance.ie/cat_news_detail.jsp?itemID=2766…
    
    

    • If caught early, Tysabri-PML not fatal for MS patients

      Alexandra Schroder, M.D., the lead investigator from Ruhr-University in Bochum, Germany points out that this is different for those who don’t have multiple sclerosis (MS) and get [...]

      • Caroline says: This is good news for Tysabri patients -- the previously always fatal PML side effect can now be controlled if caught early. ALL patients on Tysabri in the US must be monitored in the TOUCH prescribing program -- so PML is likely caught earlier.
         
      • Related Links:
      • http://www.examiner.com/x-32750-Lima-Multiple-Sclerosis-Examiner~y2010m7d22-If-c…
      
      

      • Biogen’s Tysabri Problems the Fault of European Docs?

        As mentioned in my last BNET Pharma posting, Biogen Idec’s key multiple sclerosis drug Tysabri had been linked to 23 worldwide cases of a potentially deadly brain [...]

        • Caroline says: 23 cases of PML have been confirmed in patients taking Tysabri, most of them in European countries and with an alarmingly high presence in Germany. The US has the fewest cases, and the most stringent patient monitoring program. Is this the reason there are more cases of PML in countries that aren't so strict?
           
        
        

        • Biogen Reports 2 More Cases of PML with Tysabri

          By THOMAS GRYTA Two more cases of a rare brain infection have emerged in users of the multiple-sclerosis drug Tysabri, sold by Biogen Idec Inc. and Elan [...]

          • Caroline says: Two new PML cases have been reported since Biogen stopped reporting the incidences to investors in July 2009. At least one is in Europe, and all cases reported have been in people taking Tysabri for at least a year.
             
          
          

          • 11th Case of PML Reported With Tysabri

            The 11the patient on Tysabri has developed a potentially deadly brain infection. This is what happened when three people who were on Tysabri and other medications for [...]

            • Caroline says: Biogen reports the 11th case of PML...only a few thus far have been fatal but I think we all know the implications of a PML diagnosis.
               
            
            

            • Biogen Reports 13th Case of PML

              By KEITH J. WINSTEIN Biogen Idec Inc.’s disclosure of a debilitating brain infection in a patient taking its Tysabri multiple-sclerosis medicine sparked a selloff in shares of [...]

              • Caroline says: We seemed to have skipped cases 11 and 12 because I haven't seen reports on these anywhere...Biogen STILL says a "drug holiday" is unjustified after 2 years of Tysabri and 13 cases of PML?? GIVE ME A BREAK! Give me a break! I also am appalled that I read about these cases first and only from financial journals reporting about how much their stockholders have lost because of each new PML case...WTF? This information is NOT on Biogen's website, nor is it even on their Tysabri webpage.
                 
              
              

              • 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.
                     
                  
                  
                  « Previous Entries