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 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.
     
  
  

  • 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.
       
    
    

    • 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.
         
      
      

      • 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...