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…
  
  

  • What’s the Point of Extavia?

    Featured Story Oct. 16, 2009 By Angela Maas, Managing Editor Another drug in the self-injected multiple sclerosis (MS) class recently came onto the marketplace. But many within [...]

    • Caroline says: The general consensus on Extavia (the generic form of Betaseron that received FDA approval earlier this year) is that its sole purpose is to create Novartis' entree into the MS marketplace in preparation for FTY-720. The MS market is one in which until now, Novartis has been totally unfamiliar. The strategy is clear -- but the point of Extavia is not, according to this very interesting article. Several experts note that Betaseron has the lowest market share of all interferons, and although the price of Extavia hasn't been officially released, insiders report it will cost barely less than Betaseron. The only thing in this article that I patently disagree with is that Copaxone is the most prescribed interferon...um, since when? Interesting insight into pharma marketing strategy and a fun read, nonetheless!
       
    
    

    • Novartis says FTY720 reduces relapses

      ZURICH, Sept 30 (Reuters) – Swiss drugmaker Novartis AG said on Wednesday its FTY720 oral drug to treat multiple sclerosis reduced both relapses and disability progression. Initial [...]

      • Caroline says: Oral update: Novartis is addressing the safety concerns with FTY-720. According to execs, FDA review for FTY-720 will be in the next 6 months.
         
      
      

      • 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).