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

Archive: September, 2010

 

  • 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.
       

    • Mindfulness Meditation May Ease Fatigue, Depression in MS

      Learning mindfulness meditation may help people who have multiple sclerosis (MS) with the fatigue, depression and other life challenges that commonly accompany the disease, according to a [...]

      • Caroline says: This article has popped up on several health sites many times in the last couple of days. I haven't studies meditation, so I had to read up on exactly what mindfulness meditation is, and how it differs from "traditional" meditation. Read more about mindfulness meditation here.
         

      • 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).
           

        • 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.
             

          • Gilenya wins US FDA approval

            Novartis AG won U.S. regulatory approval to sell Gilenya, beating Merck KGaA (oral clad) in a race to market the first pill to slow multiple sclerosis. The [...]

            • Caroline says: Hot off the press... Novartis' oral MS drug, Gilenya has officially been FDA approved as first-line agent for patients with RRMS. A Sept 21, 2010 approval date means Novartis will undoubtedly launch the drug this year. Gilenya is approved at a daily dose of .5 mg and will have a REMS protocol (safety monitoring system) not unlike Tysabri.
               

            • Novartis’ Multiple Sclerosis Drug Gilenya Poised for Approval

              On Tuesday, the landscape of the multiple sclerosis treatment sector is going to change dramatically — at least in theory. The FDA is set to make a [...]

              • Caroline says: Today is Novartis' PDUFA date (PDUFA means the date the FDA will make a decision on a drug's approval). As most MS patients are aware, an FDA panel unanimously recommended the approval of oral fingolimod in June 2010 (brand name in the US will be Gilenya). If the FDA approves oral fingolimod today as expected, news should be hitting the wires tonight/tomorrow...stay tuned.
                 

              • Five more cases of PML linked to Tysabri

                Biogen has reported five more cases of rare brain infection PML in patients taking Tysabari, the multiple sclerosis drug it jointly sells with Irish based Elan. This [...]

                • Caroline says: Biogen is reporting another 5 cases of Tysabri-induced PML No information is given on country of origin -- and if I had to guess I would assume the US probably has the fewest cases because of the mandatory TOUCH prescribing program. According to this article, 52,000 patients are currently taking Tysabri and the MS Society estimates that 2.5 million people worldwide have MS.
                   

                • MS Patients: Do your Fitness!

                  Multiple sclerosis (MS) is a neurological illness that results in abnormal function of the central nervous system. Despite the seriousness of the diagnosis, exercise can be therapeutic [...]

                  • Caroline says: Even more evidence that MS is not an excuse for physical inactivity! Exercise is medicine and all MS patients should be engaging in regular activity (will the permission of your neurologist, of course). If you can't walk, there are plenty of other activities in which to participate. 30-minutes of aerobic exercise per week is the recommendation -- this isn't possible for everyone, but do what you can!
                     

                  • Asthma drug albuterol improves MS when added to Copaxone

                    The asthma drug albuterol can ease the symptoms of multiple sclerosis and delay relapses when added to conventional treatments, but the effects apparently wear off after a [...]

                    • Caroline says: MS is associated with abnormal activity of an immune system chemical, or cytokine, called interleukin-12 (IL-12). IL-12 promotes production of white blood cells that attack myelin fibers. Albuterol is known to suppress the activity of IL-12, so researchers guessed it might help in MS. According to this study, however, the effects last for only a year.
                       

                    • Gilenya (oral fingolimod) Approved in RUSSIA

                      Basel, September 10, 2010- The Russian health authority, the Federal Service on Surveillance in Healthcare and Social Development, has granted approval for Gilenya (fingolimod) 0.5 mg once-daily oral therapy [...]

                      • Caroline says: Novartis AG announced the approval of oral fingolimod (brand name: Gilenya) in Russia. This is the FIRST approval for Gilenya (cladribine [Movectro] was also approved first in Russia a few weeks ago). Launch will be in early 2011 in Russia. An FDA decision is expected this month.
                         

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