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FDA approves Tecfidera/BG-12

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    FDA approves Tecfidera/BG-12

    Good news for all! BG-12 was approved by the FDA today. I understand that it will begin shipping next week. Here is the FDA announcement:


    For Immediate Release: March 27, 2013
    Media Inquiries: Stephanie Yao, 301-796-0394,
    Consumer Inquiries: 888-INFO-FDA

    FDA approves new multiple sclerosis treatment: Tecfidera

    The U.S. Food and Drug Administration today approved Tecfidera (dimethyl fumarate) capsules to treat adults with relapsing forms of multiple sclerosis (MS).

    MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is among the most common causes of neurological disability in young adults and occurs more frequently in women than men. For most people with MS, episodes of worsening function (relapses) are initially followed by recovery periods (remissions). Over time, recovery periods may be incomplete, leading to progressive decline in function and increased disability. MS patients often experience muscle weakness and difficulty with coordination and balance. Most people experience their first symptoms of MS between the ages of 20 and 40.

    “No drug provides a cure for multiple sclerosis so it is important to have a variety of treatment options available for patients,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Multiple sclerosis can impair movement, sensation, and thinking and have a profound impact on a person’s quality of life.”

    Results from two clinical trials showed that those taking Tecfidera had fewer MS relapses compared to people taking an inactive pill (placebo). One of the trials showed that those taking Tecfidera experienced a worsening of disability less often than patients taking a placebo.

    Tecfidera may decrease a person’s white blood cell count (lymphocytes). Lymphocytes help protect the body from infection and low counts can raise the risk of infection, although no significant increase in infections was seen in patients taking Tecfidera in clinical trials. Before starting treatment, and annually thereafter, the FDA recommends that the patient’s white blood cell count be assessed by their health care provider.

    Flushing (warmth and redness) and stomach problems (nausea, vomiting, and diarrhea) were the most common adverse reactions reported by patients receiving Tecfidera in clinical trials, especially at the start of therapy. These side effects may decrease over time.

    Tecfidera is made by Biogen Idec, Weston, Mass.

    At biogen conference now. Party time has begun.


      Full Tecfidera Prescribing Information

      My dad is an M.D. who worked for the FDA for many years. He sent me a link with the full prescribing information for this drug. I have high hopes for it as I know many others do also.


        Going to be asking my neuro about this at my next appt in May! Sooooo tired of the copaxone injections!



          The website has been updated with the particulars of the medication, the prescription form and they announced a $10 copay program.
          Falling down is easy... getting up not so much


            I'll be curious to see what happens with the $10 co-pay program. Even with Novartis' co-pay assist. I was paying close to $800 a year for Gilenya.

            Can't wait to switch!


              I've been on this bandwagon for well over a year now, and finally!!!!!!!!!!!!

              Thanks for nothing, Teva! Three extra months for making us wait over "no so much"?

              My doctor squeezed me in next Tuesday, because we've been waiting so long and I NEED to do something for my M.S. I pray this works for me and all other MSers who are going to try this medication. I'm beside myself with joy today--Easter, nah! IT'S CHRISTMAS!!!!!



                BG-12 PRESCRIPTION!!!



                  white cell blood count

                  My doctor wants me to come off Gilenya and go on BG12because my white cells keep dropping, but I saw in one of these messages that this new med also drops the white cells. Anybody know anything on that?


                    Reduced White Blood Cell Count

                    This is the portion of the Full Prescribing Information that deals specifically with the reduction of lymphocytes after taking Tecfidera/BG-12:

                    5.1 Lymphopenia

                    TECFIDERA may decrease lymphocyte counts [see Adverse Reactions (6.1)]. In the MS placebo controlled trials, mean lymphocyte counts decreased by approximately 30% during the first year of treatment with TECFIDERA and then remained stable. Four weeks
                    after stopping TECFIDERA, mean lymphocyte counts increased but did not return to baseline. Six percent (6%) of TECFIDERA patients and <1% of placebo patients experienced lymphocyte counts <0.5x109/L (lower limit of normal 0.91x109/L). The incidence of
                    infections (60% vs 58%) and serious infections (2% vs 2%) was similar in patients treated with TECFIDERA or placebo, respectively. There was no increased incidence of serious infections observed in patients with lymphocyte counts <0.8x109/L or 0.5x109/L. Before initiating treatment with TECFIDERA, a recent CBC (i.e., within 6 months) should be available. A CBC is recommended
                    annually, and as clinically indicated. Withholding treatment should be considered in patients with serious infections until the infection(s) is resolved. TECFIDERA has not been studied in patients with pre-existing low lymphocyte counts.

                    17.4 Lymphocyte Counts

                    Inform patients that TECFIDERA may decrease lymphocyte counts. A recent blood test (i.e., within 6 months) should be available before they start therapy to identify patients with pre-existing low lymphocyte counts. Blood tests are also recommended annually, and
                    as clinically indicated [see Warnings and Precautions (5.1), Adverse Reactions (6.1)].


                      [QUOTE=jessiesmom;1405471]My dad is an M.D. who worked for the FDA for many years. He sent me a link with the full prescribing information for this drug. I have high hopes for it as I know many others do also.

                      What about the tumors in the rats?


                        Originally posted by jessiesmom View Post

                        What about the tumors in the rats?
                        Looks like the tumors and leiomyosarcoma was seen in dosages higher than the dosage they recomend (if I'm reading it right.)

                        This part was interesting to me: "The median age was 37 years,median time since diagnosis was 3 years, and median EDSS score at baseline was 2.5. The median time on study drug for all treatment arms was 96 weeks. The percentages of patients who completed 96 weeks on study drug per treatment group were 72% for patients assigned to TECFIDERA240 mg twice a day...TECFIDERA had a statistically significant effect on the relapse and MRI endpoints described above. There was no statistically significant effect on disability progression. "

                        So the study was for those who were relatively early in their diagnosis, and had a low EDSS score...and as with the latest info after studying Betaseron for years, there is no significant effect on disability progression.

                        Add to that my recent understanding of MRIs showing a brain that is in a constant rate of changing lesions and I guess I'm a little jaded:

                        That's a little disappointing, also wondering if side effects are mild, why did 30% drop out of the study.

                        I'm going to try it and see what happens. Wonder what the cost of a month's worth of the normal dosage will be. They hadn't set up the cost yet (from what I read in another article.) We know what Avonex and Tysabri (their other products) cost. I can't imagine this will be less, but at the same time can't see how a bottle of 60 pills (the maintenance dose) could cost $3,000...that'd be 50 bucks a pill...time will tell.

                        Well, I'll be in line with everyone else giving it a chance and hoping for the bet.


                          I read on a business article that the yearly price proposed by Biogen is $50,000 (US) per year. Not sure about pricing elsewhere, and there will likely be bigger-insurance bargaining...but that's $4100 a month. Yowza!

                          My copaxone 'script is $3200/month, I pay $15 copay *phew*
                          RRMS 2011, Copaxone 2011-2013, Tecfidera 2013-current


                            Originally posted by KateA2 View Post
                            I read on a business article that the yearly price proposed by Biogen is $50,000 (US) per year. Not sure about pricing elsewhere, and there will likely be bigger-insurance bargaining...but that's $4100 a month. Yowza!

                            My copaxone 'script is $3200/month, I pay $15 copay *phew*
                            $4100 per month for 60 pills (about $68 bucks a pill.) Well I understand you're not paying for the "pill" you're paying for the research and testing, but this was already an established treatment in Europe for psoriasis.

                            I don't know, I thought that because the others injectibles include so much more than just the med, i.e. syringe, special packaging, etc. This might be a little lower, but then it is the latest and greatest, and they always charge more.

                            Wonder if insurance will make the doc prove you've failed on another DMD therapy before letting a patient use BG12. As you said, those with group insurance, will probably have to go through a special pharmacy and the insurance company will make a deal for a better price. For drugs like this, I bet it ends up on non-formulary list...our copay is 3 times what it is for regular drugs, but still not bad. I imagine they'll have an assistance program for those without insurance.

                            Time will tell.



                              I asked my neuro when I could get BG-12 and he said it cannot be prescribed yet. Something about having to wait until after the big launch meeting which would be after May 6.
                              But since I'm having those back and neck pains, I think I'm going to make an appt with my neuro soon (before the Launch Meeting).
                              I'll let you know what I hear.