Oral Cladribine Fails to Get FDA Approval

Pharmaceutical and chemical company Merck KGaA ( MRK.XE) said Wednesday the U.S. Food and Drug Administration has not approved its oral multiple sclerosis drug cladribine application in [...]

• Caroline says: Merck/EMD Serono's drug oral cladribine for RRMS has failed to receive FDA approval. The drug demonstrates substantial efficacy -- but has a questionable safety profile. Two ongoing cladribine trials (CLARTITY EXTENSION and ORACLE) will conclude at the end of 2011 and mid-2012, and if these demonstrate a desirable safety profile, Serono can re-file with the FDA.
   

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• http://www.nasdaq.com/aspx/stock-market-news-story.aspx?storyid=201103020500dowj…

• EU Rejects Merck’s Multiple-Sclerosis Pill, Cladribine

  Merck KGaA’s hopes of gaining European marketing approval for its multiple-sclerosis pill Cladribine were quashed Friday, after a European Union panel confirmed its negative opinion on the [...]

  • Caroline says: The FDA is currently reviewing cladribine (in the US it will be marketed by Serono/Pfizer), and a decision will be made about whether the drug will be approved in the US Feb 28, 2011. Apologies for the Wall Street Journal re-post, I think to view the link a log in is required but I didn't see this anywhere else. It will no doubt hit the blogs later today, when more information is available.
     
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  • http://online.wsj.com/article/SB10001424052748704754304576095441776135786.html…
  
  

  • FDA Grants Cladribine Priority Review

    July 28 (Bloomberg) — Merck KGaA said U.S. regulators granted the cladribine multiple sclerosis pill priority review, reducing to six months from 10 the time it will [...]

    • Caroline says: The FDA has granted priority review status to Merck's oral MS pill, cladribine. Priority review status reduces FDA review time from 10 months to 6...thus putting a Q4 2010 approval date possible for the second MS oral to be FDA approved this year (Novartis' Gilenia will likely receive approval in September 2010). This FDA priority review status comes on the heels of Russia's approval of cladribine earlier this month. Big news, folks.
       
    • Related Links:
    • http://www.businessweek.com/news/2010-07-28/merck-kgaa-says-fda-grants-cladribin…
    
    

    • 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…
      
      

      • Merck Refiles Cladribine for US Approval

        FRANKFURT (Dow Jones)–German pharmaceutical and chemicals company Merck KGaA (MRK.XE) said Tuesday it resubmitted its application for U.S. regulatory approval of oral multiple sclerosis treatment cladribine–seven months [...]

        • Caroline says: After the FDA refused to file their initial application in November 2009, Merck has re-filed their oral MS drug cladribine in June 2010.
           
        • Related Links:
        • http://www.reuters.com/article/idUSLDE62O0CG20100608…
        
        

        • Merck KGaA Submits Application For Cladribine Tablets In US

          Germany’s Merck KGaA has made further progress in its bid to be the first company to market an oral multiple sclerosis treatment by filing cladribine in the [...]

          • Caroline says: The oral race continues and Merck has pulled ahead just a little bit...this US filing comes a day after Novartis announced positive Phase III data for fingolimod.
             
          
          

          • Merck Discontinues Ph 2 Trial of Atacicept in MS

            September 28, 2009 by Matthew Dennis Merck KGaA has decided to discontinue Phase II clinical trials of atacicept for the treatment of multiple sclerosis based on a recommendation [...]

            
            

            • Hot off the ECTRIMS Press…Cladribine Reduces Disease Activity in a Big Way

              Darmstadt, Germany, September 11, 2009 – Merck KGaA announced today new data from a post-hoc analysis of the two-year (96-week) placebo-controlled CLARITY(1) Phase III trial using a [...]

              • Caroline says: These data are significant! Two-year data were released at ECTRIMS showing that 44% of patients treated with cladribine had no disease activity compared with 16% on placebo. Merck submitted their EMEA approval application in July 2009 and will file it in other countries, including the US, in Q3...meaning the end of this month, I believe.
                 
              
              

              • Merck Sumbits Cladribine Application for EU Approval

                July 23, 2009 — 9:05am ET | By John Carroll Racing to beat Novartis to the world’s biggest drug markets with a new oral therapy for multiple sclerosis, [...]

                • Caroline says: Merck has submitted their Cladribine application in the EU today. They will submit their US application later this quarter. They filed just ahead of Novartis (FTY-720). The orals are not too far away from market approval!
                   
                
                

                • Hot off the AAN Press: Cladribine Reduces Relapses, Disability, Disease Progression

                  April 29, 2009 Merck KGaA on Wednesday presented detailed results from a previously announced Phase III study of investigational oral multiple sclerosis drug cladribine at the American [...]

                  • Caroline says: 1326 patients received cladribine or placebo in a 2-year study. According to Merck, the findings demonstrated that annual short-course treatment with cladribine significantly reduced the rate of clinical relapses, disability progression and brain lesions in patients with relapsing-remitting MS, and also led to a significant increase in the proportion of patients who remained relapse-free. And it's an oral...