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 Oral cladribine is currently approved in Russia and Australia, and will be withdrawn from the markets there as well, according to this article.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…

• HOT off the ECTRIMS Press: Rebif Prefilled Pen

  Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today the upcoming introduction of the new device RebiDose(TM), the Rebif(R) single use pre-filled pen, for the [...]

  • Caroline says: I'm actually surprised that this is just coming out now for Rebif. The autoject pre-filled dose pens have been around for years for other MS injectables.
     
  • Related Links:
  • http://www.prnewswire.co.uk/cgi/news/release?id=300836…
  
  

  • 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…
    
    

    • HOT off the EFNS Press: PWMS Treated With Cladribine Remain Progression-Free

      September 29, 2010 — A large proportion of patients with relapsing-remitting multiple sclerosis (MS) remained relapse-free following cladribine treatment at either of 2 dose levels, according to [...]

      • Caroline says: These findings from the European Federation of Neurological Societies (EFNS) meeting today in Geneva are interesting, especially given the fact that the European Medicines Agency (EMA) gave an unfavorable opinion of cladribine because of safety concerns last week. This is good news, however, for MS patients interested in oral agents. The FDA will most likely grant approval for cladribine for MS this December. The negative EMA opinion means it will most likely have a stringent safety monitoring program for patients for whom it is prescribed in the US. Approval in Europe may not be likely anytime soon.
         
      • Related Links:
      • http://www.docguide.com/news/content.nsf/news/852576140048867C852577AD0058747E…
      
      

      • 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…
            
            

            • Hot off the ENS Press: Cladribine Is Safe Overall in Patients With Multiple Sclerosis

              MILAN, Italy — June 24, 2009 — According to a safety analysis of a study presented here at the 19th Meeting of the European Neurological Society (ENS), [...]

              • Caroline says: This is good news for people who are excited about orals. Cladribine seems to be the safer option out of the ones that are coming out soon. Incidence of treatment-emergent AE's in the trial of 1326 RRMS patients were comparable between 2 doses of cladribine and placebo. As expected based on the MOA of cladribine, lymphopenia (low white blood cells) occurred with the highest incidence in patients receiving the higher dose of the drug.
                 
              
              

              • LATE BREAKING: New Phase III Data for Cladribine to be Presented at AAN

                CLARITY (CLAdRIbine tablets Treating MS OrallY) Study Data to be Presented as Late-Breaking Oral Presentation By: PR Newswire Mar. 30, 2009 08:01 AM GENEVA, Switzerland, March 30 [...]

                • Caroline says: AAN has accepted a late-breaking oral presentation on Merck/Serono's oral cladribine Phase III results. Most medical conferences decide what abstracts and subject matter they're approving months before the actual congress. So, this means that the investigator of this study has some potentially new and riveting findings for us. The abstract is embargoed until AAN, but this could be big news for all you oral fans...