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…
  
  

  • 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…
      
      

      • Oral cladribine rejected by European Drug Agency

        Merck trails Novartis in the race to provide MS patients with a pill in the U.S., where the Swiss drugmaker won approval on Sept. 22 for its [...]

        • Caroline says: This is a big blow to oral cladribine, which is currently on fast-track status for a possible FDA approval in December 2010. Gilenya is an oral pill taken daily, while cladribine is taken on a short course a few times a year...and a concern with that dosing may be the drug's long term effects on the immune system.
           
        • Related Links:
        • http://www.bloomberg.com/news/2010-09-24/merck-kgaa-multiple-sclerosis-pill-is-r…
        
        

        • 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…
          
          

          • Novartis’ Multiple Sclerosis Drug Gilenya Poised for Approval

            On Tuesday, the landscape of the multiple sclerosis treatment sector is going to change dramatically — at least in theory. The FDA is set to make a [...]

            • Caroline says: Today is Novartis' PDUFA date (PDUFA means the date the FDA will make a decision on a drug's approval). As most MS patients are aware, an FDA panel unanimously recommended the approval of oral fingolimod in June 2010 (brand name in the US will be Gilenya). If the FDA approves oral fingolimod today as expected, news should be hitting the wires tonight/tomorrow...stay tuned.
               
            • Related Links:
            • http://www.minyanville.com/businessmarkets/articles/ms-multiple-sclerosis-ms-tre…
            
            

            • 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…