cladribine approvals

This is the archive for cladribine approvals.

• Merck KGaA pulls plug on cladribine on FDA feedback

  (Reuters) – Merck KGaA said U.S. drug regulators’ concerns about the risks of its cladribine pill will put an end to any development or marketing plans for [...]

  • Caroline says: Merck/Serono will not pursue an MS approval for oral cladribine. The drug was rejected by the FDA in March 2011 because of safety concerns. Oral cladribine is currently approved in Russia and Australia, and will be withdrawn from the markets there as well, according to this article.
     
  • Related Links:
  • http://uk.reuters.com/article/2011/06/22/health-us-merckkgaa-cladribine-idUKTRE7…
  
  

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

    • FDA Rejects Oral Cladribine

      The US Food and Drug Administration (FDA) wants more information about Cladribine, an oral treatment for multiple sclerosis developed by Merck KGaA The European Medicines Agency (EMEA) [...]

      • Caroline says: The FDA has rejected oral cladribine, which if approved would have been the second oral for the treatment of relapsing MS. The FDA cited safety issues as the primary reason for rejection. Oral cladribine is currently approved in Russia and Australia.
         
      • Related Links:
      • http://www.firstwordpharma.com/node/840284…
      
      

      • 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.
           
        • Related Links:
        • http://online.wsj.com/article/SB10001424052748704754304576095441776135786.html…
        
        

        • FDA Delays Approval of Oral Cladribine for 3 Months

          The Food and Drug Administration extended the pill’s priority review period by three months to Feb. 28, 2011, to examine additional information on the product, Darmstadt, Germany-based [...]

          • Caroline says: This is big news! Oral cladribine was slated for US FDA approval in 2010, meaning it should have been approved any day. The FDA has extended the review time for oral cladribine for 3 months, which means the decision to approve it will now be in February 2011.
             
          • Related Links:
          • http://www.businessweek.com/news/2010-11-26/merck-kgaa-says-fda-extends-review-f…
          
          

          • Merck to Appeal Negative Panel View on Cladribine

            Merck KGaA (MRK.XE) said Monday it plans to appeal the negative assessment reached by a European drug advisory panel on the use of its new multiple sclerosis [...]

            • Caroline says: Merck will appeal the European Medicines Agency's negative assessment of cladribine. The majority of appeals are rejected, according to this article, which means the hope of a cladribine approval in Europe may be a pipe dream. The US FDA decision is expected in December 2010.
               
            • Related Links:
            • http://www.foxbusiness.com/markets/2010/10/11/merck-kgaa-appeal-european-panel-v…
            
            

            • 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…
              
              

              • Merck May Appeal EMA Negative Cladribine Opinion

                Merck may appeal a negative opinion on its multiple sclerosis pill Cladribine made by an advisory panel of the European Medicines Agency, Merck KGaA said Friday. The [...]

                • Caroline says: After an unfavorable review by the European Medicines Agency (Europe's FDA) for it's MS drug oral cladribine, Merck hints it may appeal the agency's decision. Oral cladribine has been approved in Russia and Australia and will receive a US FDA decision in December 2010. If oral cladribine is approved in the US as expected, it will no doubt be under strict REMS guidelines, so patients will be monitored very closely (think Tysabri's TOUCH program).
                   
                • Related Links:
                • http://www.advfn.com/news_UPDATE-Merck-KGaA-May-Appeal-Negative-Cladribine-Opini…
                
                

                • 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…
                  
                  

                  • Movectro (oral cladribine) Approved in AUSTRALIA

                    Merck KGaA announced that the Australian Therapeutic Goods Administration (TGA) has approved Cladribine Tablets for the treatment of relapsing-remitting multiple sclerosis (MS). Cladribine Tablets will be registered [...]

                    • Caroline says: The Australian Therapeutic Goods Association (TGA) has approved oral cladribine for patients with RRMS. Trade name "Movectro" -- this follows the Russian approval in July 2010...a US FDA decision is expected towards the end of 2010.
                       
                    • Related Links:
                    • http://www.medicalnewstoday.com/articles/200046.php…
                    
                    
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