Posting fresh info about MS, for people with MS and their supporters

  • 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.
       

    • 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.
         

      • 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.
           

        • 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.
             

          • 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!
               

            • 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.
                 

              • 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).
                   

                • 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.
                     

                  • 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.
                       

                    • 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.
                         

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