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…
  
  

  • Study finds that most neurologists plan to prescribe oral MS drugs when approved this year

    Majestic Research Study Indicates that Neurologists’ Apprehension Regarding Side Effects Won’t Stop Them from Prescribing New Oral MS Drugs, but Concerns Will Likely Relegate Their Use to [...]

    • Caroline says: A recent study showed that 84% of neurologists polled plan to prescribe Novartis' Gilenia (FTY-720) and Serono's cladribine for some of their RRMS patients when they are approved later this year (end of September for Gilenia, later in 2010 for cladribine). However, until safety concerns for both drugs are resolved, they will most likely be prescribed as second-line and third-line agents, despite the fact that their FDA approval will probably be as first-line agents.
       
    • Related Links:
    • http://www.fiercepharma.com/story/tevas-oral-laquinimod-ms-gets-fast-tracked/200…
    
    

    • 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…