current therapies

This is the archive for current therapies.

• HOT off the ECTRIMS Press: Rebif Prefilled Pen

  Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today the upcoming introduction of the new device RebiDose(TM), the Rebif(R) single use pre-filled pen, for the [...]

  • Caroline says: I'm actually surprised that this is just coming out now for Rebif. The autoject pre-filled dose pens have been around for years for other MS injectables.
     
  • Related Links:
  • http://www.prnewswire.co.uk/cgi/news/release?id=300836…
  
  

  • Physicians Eager to Embrace Orals (the MS orals, not the other kind)

    Physicians are anticipating the arrival of new oral therapies for multiple sclerosis patients, with initial research showing very high awareness of oral candidates, particularly Novartis’ Gilenya, which [...]

    • Caroline says: I couldn't help smiling when I read this headline...but all joking aside, according to this article, 80% of physicians are aware of Gilenya and 60% are aware of cladribine. The oral revolution is upon us!
       
    • Related Links:
    • http://www.kansascity.com/2010/10/12/2303130/physicians-eager-to-embrace-new.htm…
    
    

    • Novartis Gilenya MS Pill to Cost $48,000 a Year

      Novartis AG’s multiple sclerosis pill Gilenya will cost $4,000 a month in the U.S., according to a company spokesman. Novartis has set a wholesale price at about [...]

      • Caroline says: Novartis' Gilenya will cost between $30-$48K/year (I have read differing cost estimates). It will be on formularies -- but nonetheless this price tag is more than interferons, which are not cheap.
         
      • Related Links:
      • http://www.bloomberg.com/news/2010-09-30/novartis-gilenya-ms-pill-to-cost-48-000…
      
      

      • Gilenya wins US FDA approval

        Novartis AG won U.S. regulatory approval to sell Gilenya, beating Merck KGaA (oral clad) in a race to market the first pill to slow multiple sclerosis. The [...]

        • Caroline says: Hot off the press... Novartis' oral MS drug, Gilenya has officially been FDA approved as first-line agent for patients with RRMS. A Sept 21, 2010 approval date means Novartis will undoubtedly launch the drug this year. Gilenya is approved at a daily dose of .5 mg and will have a REMS protocol (safety monitoring system) not unlike Tysabri.
           
        • Related Links:
        • http://www.bloomberg.com/news/2010-09-22/novartis-awarded-u-s-approval-for-ms-pi…
        
        

        • 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…
          
          

          • Asthma drug albuterol improves MS when added to Copaxone

            The asthma drug albuterol can ease the symptoms of multiple sclerosis and delay relapses when added to conventional treatments, but the effects apparently wear off after a [...]

            • Caroline says: MS is associated with abnormal activity of an immune system chemical, or cytokine, called interleukin-12 (IL-12). IL-12 promotes production of white blood cells that attack myelin fibers. Albuterol is known to suppress the activity of IL-12, so researchers guessed it might help in MS. According to this study, however, the effects last for only a year.
               
            • Related Links:
            • http://www.latimes.com/health/boostershots/la-heb-multiple-sclerosis-20100913,0,…
            
            

            • Gilenya (oral fingolimod) Approved in RUSSIA

              Basel, September 10, 2010- The Russian health authority, the Federal Service on Surveillance in Healthcare and Social Development, has granted approval for Gilenya (fingolimod) 0.5 mg once-daily oral therapy [...]

              • Caroline says: Novartis AG announced the approval of oral fingolimod (brand name: Gilenya) in Russia. This is the FIRST approval for Gilenya (cladribine [Movectro] was also approved first in Russia a few weeks ago). Launch will be in early 2011 in Russia. An FDA decision is expected this month.
                 
              • Related Links:
              • http://www.reuters.com/article/idUS41800+10-Sep-2010+HUG20100910…
              
              

              • Movectro (oral cladribine) Approved in AUSTRALIA

                Merck KGaA announced that the Australian Therapeutic Goods Administration (TGA) has approved Cladribine Tablets for the treatment of relapsing-remitting multiple sclerosis (MS). Cladribine Tablets will be registered [...]

                • Caroline says: The Australian Therapeutic Goods Association (TGA) has approved oral cladribine for patients with RRMS. Trade name "Movectro" -- this follows the Russian approval in July 2010...a US FDA decision is expected towards the end of 2010.
                   
                • Related Links:
                • http://www.medicalnewstoday.com/articles/200046.php…
                
                

                • 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…
                  
                  

                  • EX-US: First Oral Approved for PWMS: Cladribine approved in RUSSIA

                    Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that the Russian Federal Service on Surveillance in Healthcare and Social Development has become the first [...]

                    • Caroline says: The Russian approval of Merck's cladribine marks approval of the FIRST oral MS drug in the world. The Russian Federal Service on Surveillance in Healthcare and Social Development (Russia's FDA) has approved Cladribine for RRMS. It will be marketed under the brand name Movectro and Russian launch is expected in early 2011.
                       
                    • Related Links:
                    • http://www.prnewswire.co.uk/cgi/news/release?id=291909…
                    
                    
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