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…

• HOT off the AAN 2011 Press: Biogen MS drug meets main goal in late-stage study

  Biogen Idec Inc’s experimental multiple sclerosis drug met the main goal in the first of two important late-stage studies, the U.S. biotechnology company said on Monday. The [...]

  • Caroline says: More good news for you oral fans...Biogen is presenting top line data at this year's American Academy of Neurology (AAN) meeting in Honolulu. The meeting is happening this week.
     
  • Related Links:
  • http://www.reuters.com/article/2011/04/11/us-biogen-idUSTRE73A2G420110411…
  
  

  • 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…
    
    

    • HOT off the ECTRIMS Press: Roche’s ocrelizumab reduces MS relapse rates in mid-stage trial

      The 24-week trial randomised 220 patients to receive one of two doses of ocrelizumab or placebo given at day one and day 15. Data show that the [...]

      • Caroline says: In Phase II trial data presented at ECTRIMS this year, Roche and Biogen's agent ocrelizumab halted MS relapses by an astounding 73%. Ocrelizumab was being studied for rheumatoid arthritis but discontinued due to safety concerns.
         
      • Related Links:
      • http://www.firstwordplus.com/Fws.do?articleid=F2150D7CD79942CEB4A639BAAEA802B5…
      
      

      • 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…
          
          

          • Abbott enters final clinical trial of MS drug

            Abbott Laboratories and its Massachusetts biotech partner have launched a final-stage clinical trial of their experimental treatment for multiple sclerosis. The first of an eventual 1,500 patients [...]

            • Caroline says: Abbott Labs and Biogen announced today that first clinical trials using daclizumab and PWMS will begin. Daclizumab is monoclonal antibody and will be administered in the form of a monthly injection.
               
            • Related Links:
            • http://www.chicagotribune.com/business/ct-biz-0624-notebook-health-20100623,0,13…
            
            

            • 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?
                 
              
              

              • Don’t Hold Your Breath For Generic Avonex

                September 16, 2009 — 11:47am ET | By George Miller Biogen Idec has succeeded in extending patent protection for its multiple sclerosis drug Avonex to 2026, some [...]

                • Caroline says: I think this is lame. Lame for patients who can't afford to spend $50/month on Avonex (that's what mine costs, anyway), and lame on the part of Biogen to get around patent expiration laws that are in effect for a reason. A lower cost, generic version of Avonex will not be available until 2026 -- that's a full 13 years beyond the original patent granted to Biogen. Shame on you, Biogen.
                   
                
                

                • 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.
                     
                  
                  
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