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…
  
  

  • 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…
      
      

      • Gilenia (oral fingolimod) Coming Soon to Pharmacies Near You

        Basel, June 10, 2010 – Today, an advisory committee of the US Food and Drug Administration (FDA) recommended approval of FTY720 (fingolimod) for the treatment of patients [...]

        • Caroline says: "Soon" as in early 2011, most likely. This Novartis press release gives more info regarding FDA review time and drug information.
           
        • Related Links:
        • http://www.novartis.com/newsroom/media-releases/en/2010/1423236.shtml…
        
        

        • FDA Panel Unanimously Recommends Approval of First Oral MS Drug

          A Food and Drug Administration advisory panel on Thursday unanimously recommended approval of the first drug for multiple sclerosis (MS) that can be taken orally. Existing drugs [...]

          • Caroline says: This is really great news for all you oral fans...Novartis should get FDA approval in September 2010 (this drug was given priority review). So, launch date could be late this year or early 2011.
             
          • Related Links:
          • http://latimesblogs.latimes.com/booster_shots/2010/06/fda-advisory-panel-recomme…
          
          

          • Hot off the AAN Press: Fingolimod effective but safety an issue

            UPDATE 3-Novartis MS drug effective but safety an issue ZURICH, April 29 (Reuters) – Novartis AG  said 80-83 percent of those taking its multiple sclerosis drug FTY720 [...]

            • Caroline says: Novartis presented Phase III results showing an annual relapse rate of 52% lower than Biogen's Avonex. That's significant. Safety issues abound with fingolimod though, but as we saw with Tysabri, many patients choose to accept these risks if it means more control of their disease.
               
            
            

            • Novartis MS drug linked to new side effect

              LONDON, April 14 — Fresh side-effect problems have emerged with Novartis AG’s experimental oral multiple sclerosis (MS) drug FTY720, with doctors reporting a case of haemorrhaging focal [...]

              • Caroline says: Well, this indicates that the 11 emerging drugs everyone has been excited about could be down to 10 (5 orals)...Novartis reports that a patient in their Phase III clinical trial developed haemorrhaging focal encephalitis (I had to look this up, but in simple terms, brain swelling followed by a bleed). This case was in addition to 2 patients in previous clinical trials had infections, one of which was fatal. Not good news for FTY-720 (fingolimod).
                 
              
              

              • The Age of Orals: Who Will Win the Race to the Market?

                Jan 23, 2009 Oral Cladribine Reduces MS Relapses in Phase 3 Clinical Trial Oral cladribine (EMD Serono) reduced the relapse rate significantly more than inactive placebo in [...]

                • Caroline says: OK, OK I know I said I am not excited about orals, and I'm not. HOWEVER, I respect the fact that MANY, MANY of you are and will therefore continue to post fresh updates about their introduction. First-to-market advantage is not a trivial matter! Cladribine has fast track FDA status, Serono anticipates approval in mid-2009 (that's just a few months away). Teva's Laquinimod also has fast track status and is in Phase III trials. Novartis' FTY720 (fingolimod) also plans to file in mid-2009. Who will win?? It's getting...dare I say...exciting!!
                   
                • Related Links:
                • http://www.fiercepharma.com/story/tevas-oral-laquinimod-ms-gets-fast-tracked/200…