current therapies

This is the archive for current therapies.

• HOT off the CMSC Press: Rebif at first sign of MS delays progression

  Starting interferon-beta-1a (Rebif New Formulation) immediately upon an episode of a clinically isolated syndrome delayed progression to full-blown multiple sclerosis, but once-weekly treatment was less effective than [...]

  • Caroline says: Rebif is more effective than Avonex at delaying time to diagnosis of clinically definite MS after a first clinical event (CIS), according to researchers at the annual consortium of MS centers. The study's purpose was to determine if more frequent interferon dosing was more effective than once-weekly dosing.
     
  • Related Links:
  • http://www.mstrust.org.uk/news/recentstories/article.jsp?id=4737…
  
  

  • 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…
    
    

    • Novartis Wins EU Regulatory Approval for MS Pill Gilenya

      Novartis AG (NOVN) won European approval to sell its multiple sclerosis medicine Gilenya for patients with active or severe forms of the disease. The European Commission cleared [...]

      • Caroline says: Patients with relapsing MS are now able to be prescribed Gilenya -- the first oral MS disease modifying drug. Gilenya was approved in the US in Sept 2010 as the first oral for MS. Curiously, Gilenya received second-line approval in the EU (the US FDA granted it first-line approval last year).
         
      • Related Links:
      • http://www.bloomberg.com/news/2011-03-21/novartis-wins-eu-approval-for-gilenya-m…
      
      

      • Novartis’ Oral Fingolimod (Gilenya) Approved in Canada

        The first oral drug to treat multiple sclerosis has been approved for use in Canada, a development that comes as many patients remain fixated on a controversial [...]

        • Caroline says: As expected, Novartis' Gilenya has been approved for use in Canada. According to this article, Gilenya will cost $31,000/year in Canada, and Novartis is working to get it approved by Canadian insurance companies.
           
        • Related Links:
        • http://www.theglobeandmail.com/life/health/daily-pill-for-multiple-sclerosis-get…
        
        

        • Plasma Exchange Effective in Treating Severe MS Relapses, New AAN Guideline Recommends

          A new guideline from the American Academy of Neurology recommends using plasma exchange to treat people with severe relapses in multiple sclerosis (MS) and related diseases, as [...]

          • Caroline says: This is encouraging for those with RRMS...according to this article, plasma exchange did not help those with progressive MS. The idea is that the plasma exchange helps remove plasma factors thought to play a role in activating autoimmune disease.
             
          • Related Links:
          • http://www.sciencedaily.com/releases/2011/01/110117161437.htm…
          
          

          • Teva says FDA won’t approve new version of Copaxone

            The Jerusalem-based company received a complete response letter, which means the FDA informed the company it is not willing to approve the drug at this time. Teva [...]

            • Caroline says: The FDA has declined to approve a new formulation of Copaxone for RRMS. The currently approved injectable dose is 20 mg of glatiramer acetate in one milliliter of solution, and Teva is trying for 20 mg of glatiramer acetate in half a milliliter of solution (read: more side effects). Teva may need to run an additional clinical trial showing the new version works as well as the old version.
               
            • Related Links:
            • http://www.bloomberg.com/news/2010-12-23/teva-says-fda-won-t-approve-new-version…
            
            

            • World’s first stem cell trial for stroke patients

              The elderly man was injected with roughly two million neural stem cells at Southern General Hospital in Glasgow. They hope the stem cells will help the man [...]

              • Caroline says: Stem cells are a very promising hope for many patients, not just those with MS of course. This article is important because it marks the first trial to test the safety and feasibility of stem cell implantation.
                 
              • Related Links:
              • http://www.telegraph.co.uk/health/healthnews/8137163/Worlds-first-stem-cell-tria…
              
              

              • FDA approves Nuedexta for psudobulbar affect in MS

                “This FDA approval represents a significant step forward for people who live with the debilitating effects of PBA,” said Dr. Nicholas LaRocca, Vice President of Healthcare Delivery [...]

                • Caroline says: Pseudobulbar affect (PBA) was a new term for me. It refers to "emotional incontinence" or "involuntary emotional expression disorder" (IEED) found in patients with neurologic diseases like MS. Emotional incontinence/IEED refers to episodes of uncontrolled laughing or crying. PBA/IEED affects approximately 10% of MS patients. Read more about PBA/IEED here.
                   
                • Related Links:
                • http://www.b2i.us/profiles/investor/ResLibraryView.asp?ResLibraryID=41367&GoTopa…
                
                

                • 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: Copaxone after CIS delays MS onset

                    The study reached both its primary and secondary clinical and MRI endpoints, all of which were significantly positive. Earlier initiation of treatment with Copaxone significantly slowed the [...]

                    • Caroline says: Most of the CRABS have now been approved to treat a CIS (clinically isolated syndrome). The data are compelling that early initiation after a first incidence of possible MS can delay disease onset.
                       
                    • Related Links:
                    • http://www.marketwatch.com/story/early-initiation-of-treatment-with-copaxone-r-p…
                    
                    
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