No announcement yet.

Tecfidera (BG-12) approved by FDA today!

  • Filter
  • Time
  • Show
Clear All
new posts

  • Tecfidera (BG-12) approved by FDA today!

    Biogen Idec’s TECFIDERA™ (Dimethyl Fumarate) Approved in US as a First-Line Oral Treatment for Multiple Sclerosis


    - Offers a Broad Spectrum of Patients with Relapsing Forms of MS an Effective and Convenient Treatment Option -

    - Reduces Relapses and Disability Progression -

    - Strengthens Biogen Idec’s Portfolio of Innovative Treatments for People Living with MS -

    WESTON, Mass.--(BUSINESS WIRE)--Mar. 27, 2013-- Today Biogen Idec (NASDAQ: BIIB) announced that the U.S. Food and Drug Administration (FDA) has approved TECFIDERA™ (dimethyl fumarate), a new first-line oral treatment for people with relapsing forms of multiple sclerosis (MS). Biogen Idec will make this oral capsule available to people living with MS in the United States in the coming days.

    TECFIDERA has been clinically proven to significantly reduce important measures of disease activity, including relapses and development of brain lesions, as well as to slow disability progression over time, while demonstrating a favorable safety and tolerability profile.

    “With the FDA approval of TECFIDERA, we will offer the MS community a treatment with strong efficacy and a favorable safety profile in the convenience of a pill – a combination we believe will have a significant positive impact on the way people live with this chronic disease,” said George A. Scangos, Ph.D., chief executive officer of Biogen Idec. “Biogen Idec is committed to delivering innovative treatments and setting new standards for the next generation of medicines. We believe TECFIDERA will raise expectations for what people living with MS can achieve with their therapy.”

    The FDA approval of TECFIDERA is based on data from a robust clinical development program that included DEFINE and CONFIRM, two global Phase 3 studies that enrolled more than 2,600 patients. In the ongoing extension study, ENDORSE, some patients receiving TECFIDERA have been followed for more than four years.

    In DEFINE, TECFIDERA, administered twice daily, significantly reduced the proportion of patients who relapsed by 49 percent (p<0.0001), the annualized relapse rate (ARR) by 53 percent (p<0.0001), and 12-week confirmed disability progression, as measured by the Expanded Disability Status Scale (EDSS), by 38 percent (p=0.0050) compared to placebo at two years. In CONFIRM, twice-daily TECFIDERA significantly reduced ARR by 44 percent (p<0.0001) and the proportion of patients who relapsed by 34 percent (p=0.0020) compared to placebo at two years. While not statistically significant, TECFIDERA showed a 21 percent reduction in 12-week confirmed disability progression in CONFIRM. Both studies also showed that TECFIDERA significantly reduced lesions in the brain compared to placebo, as measured by magnetic resonance imaging (MRI).

    “In clinical trials, patients treated with dimethyl fumarate had less disease activity when compared to patients on placebo – whether they were in the early stages of MS or had more established disease,” said Robert Fox, M.D., medical director of the Mellen Center for Multiple Sclerosis at Cleveland Clinic, lead investigator of the CONFIRM study, and a paid advisor for Biogen Idec for projects not related to TECFIDERA clinical development. “With the efficacy, safety and tolerability measures seen in CONFIRM, this drug provides physicians with an important additional treatment option for their patients across the MS spectrum.”

    The most common side effects associated with TECFIDERA are flushing and gastrointestinal (GI) events (i.e., diarrhea, nausea and abdominal pain). In clinical studies, flushing symptoms usually began soon after initiating treatment, were mostly mild to moderate, and usually improved or resolved over time. The incidence of GI events was higher early in the course of treatment (primarily in the first month) and decreased over time. Overall, clinical trial discontinuations due to flushing and GI events were low.

    TECFIDERA may decrease lymphocyte counts in some patients. In clinical studies, mean lymphocyte counts decreased during the first year of treatment and then remained stable. The incidence of infections and serious infections was similar in TECFIDERA-treated patients and those on placebo. There were no opportunistic infections in TECFIDERA-treated patients. In patients with low lymphocyte counts, there was no increased incidence in serious infections. Patients taking TECFIDERA should have a complete blood count (CBC) before starting treatment to measure lymphocyte counts. A follow up CBC is recommended annually and at the discretion of the treating physician.

    “We are pleased to see a new, needed treatment option available to people living with MS,” said Dr. Timothy Coetzee, chief research officer at the National MS Society. “With the collaborative focus on MS research around the world, it is an exceptionally encouraging time for those who have been diagnosed with relapsing forms of MS.”

    TECFIDERA marks the fourth therapy Biogen Idec offers worldwide to people living with MS.

    Additional TECFIDERA Updates
    On March 22, 2013 the Committee for Medicinal Products for Human Use (CHMP) in the European Union (EU) issued a positive opinion recommending a marketing authorization be granted for TECFIDERA as a first-line oral treatment for adults with relapsing-remitting multiple sclerosis (RRMS). The CHMP's recommendation has now been referred to the European Commission (EC), which grants marketing authorization for medicines in the European Union.
    On March 19, 2013, the United States Patent and Trademark Office issued a patent covering the dosing regimen of daily administration of 480 mg of TECFIDERA. This patent will expire in 2028.
    The European Patent Office recently determined that Biogen Idec’s application for a patent covering the dosing regimen of daily administration of 480 mg of TECFIDERA is allowable. Once granted, the EU patent would also expire in 2028.

    TECFIDERA is also currently under review by regulatory authorities in Australia, Canada and Switzerland.

    For more information on TECFIDERA, prescribing information and financial assistance programs go to or

    For members of the media interested in more information and additional resources, please visit

    About TECFIDERA™

    TECFIDERA delayed-release capsules are indicated for the treatment of patients with relapsing forms of MS. TECFIDERA has been proven to reduce MS relapses, progression of disability and MS brain lesions. The efficacy and safety of TECFIDERA has been studied in a large, global clinical program with more than 3,600 MS patients, which includes an ongoing long-term extension study. It is believed that TECFIDERA provides a new approach to treating MS by activating the Nrf2 pathway, although its exact mechanism of action is unknown. This pathway provides a way for cells in the body to defend themselves against inflammation and oxidative stress caused by conditions like MS.

    The starting dose for TECFIDERA is 120 mg twice a day orally. After seven days, the recommended dose increases to 240 mg twice a day orally.

    The most common adverse reactions for TECFIDERA were flushing, mostly mild to moderate in nature, and GI events (i.e., diarrhea, nausea, abdominal pain). These events are most common at the start of therapy and usually decrease over time.

    TECFIDERA may decrease lymphocyte counts. Before starting treatment with TECFIDERA, a recent CBC (i.e., within six months) should be available. A CBC is recommended annually and as clinically indicated. TECFIDERA has not been studied in patients with pre-existing low lymphocyte counts and caution should be exercised when treating these patients.

    TECFIDERA has a Pregnancy Category C. Before starting treatment with TECFIDERA, women should talk to their doctor if they are pregnant or planning to become pregnant.

    For complete TECFIDERA prescribing information, please visit
    Dave Bexfield

  • #2
    N Engl J Med. 2012 Sep 20;367(12):1098-107.

    Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis.
    Gold R, Kappos L, Arnold DL, Bar-Or A, Giovannoni G, Selmaj K, Tornatore C, Sweetser MT, Yang M, Sheikh SI, Dawson KT; DEFINE Study Investigators.


    Department of Neurology, St. Josef-Hospital/Ruhr-University Bochum, Bochum, Germany.

    Erratum in
    N Engl J Med. 2012 Dec 13;367(24):2362.


    BG-12 (dimethyl fumarate) was shown to have antiinflammatory and cytoprotective properties in preclinical experiments and to result in significant reductions in disease activity on magnetic resonance imaging (MRI) in a phase 2, placebo-controlled study involving patients with relapsing-remitting multiple sclerosis.

    We conducted a randomized, double-blind, placebo-controlled phase 3 study involving patients with relapsing-remitting multiple sclerosis. Patients were randomly assigned to receive oral BG-12 at a dose of 240 mg twice daily, BG-12 at a dose of 240 mg three times daily, or placebo. The primary end point was the proportion of patients who had a relapse by 2 years. Other end points included the annualized relapse rate, the time to confirmed progression of disability, and findings on MRI.

    The estimated proportion of patients who had a relapse was significantly lower in the two BG-12 groups than in the placebo group (27% with BG-12 twice daily and 26% with BG-12 thrice daily vs. 46% with placebo, P<0.001 for both comparisons). The annualized relapse rate at 2 years was 0.17 in the twice-daily BG-12 group and 0.19 in the thrice-daily BG-12 group, as compared with 0.36 in the placebo group, representing relative reductions of 53% and 48% with the two BG-12 regimens, respectively (P<0.001 for the comparison of each BG-12 regimen with placebo). The estimated proportion of patients with confirmed progression of disability was 16% in the twice-daily BG-12 group, 18% in the thrice-daily BG-12 group, and 27% in the placebo group, with significant relative risk reductions of 38% with BG-12 twice daily (P=0.005) and 34% with BG-12 thrice daily (P=0.01). BG-12 also significantly reduced the number of gadolinium-enhancing lesions and of new or enlarging T(2)-weighted hyperintense lesions (P<0.001 for the comparison of each BG-12 regimen with placebo). Adverse events associated with BG-12 included flushing and gastrointestinal events, such as diarrhea, nausea, and upper abdominal pain, as well as decreased lymphocyte counts and elevated liver aminotransferase levels.

    In patients with relapsing-remitting multiple sclerosis, both BG-12 regimens, as compared with placebo, significantly reduced the proportion of patients who had a relapse, the annualized relapse rate, the rate of disability progression, and the number of lesions on MRI. (Funded by Biogen Idec; DEFINE number, NCT00420212.).
    Dave Bexfield


    • #3

      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.

      For more information:
      • National Institute of Neurological Disorders and Stroke: Multiple Sclerosis Information Page
      • Innovation in Development of Drugs and Biological Products

      The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
      Dave Bexfield


      • #4
        I've started the process to get on this med. Called the neuro on the 4th. Today I was told I have an MRI and bloodwork (CBC) scheduled for the 12th.

        Mt neuro asked if I really thought I needed it, since I've been stable (or better) since my diagnosis in 2000. I said YES I'd like to stay stable as long as possible. I feel every day is pushing my luck.

        My biggest fear is rocking this stable boat.


        • #5
          stalling on making the switch

          My neuro today suggested that I switch from Copaxone to Tecfidera today. After my experience with Gilenya, I have declined for now. I am going to wait at least 6 months and see what the initial reports are with widespread usage.
          It is expected the Tecfidera will be very widely used. So far, the safety profile looks better than Gilenya. I would love to quit Copaxone...



          • #6
            Switching from Copaxone to Tecfidera

            I have been on Copaxone since March 2012 (DX Dec 2011, haven't tried anything else). I decided to run a 1/2 marathon in late April and then a few days later went into my first major relapse since my diagnosis. After the IV steroids, my neuro thought I should give Tecfidera a try. If approved by my insurance (50/50 chance, I'm told), I should start it in the next 2-3 weeks. I am having new MRI's done next week and if they still look good, I might stay on Copaxone. I don't like the idea of possible liver damage or some type of leukemia that seem to be common in other DMDs.


            • #7
              MM1, hope your MRI went well. Just an FYI, for leukemia, Novantrone is the one DMD that statistically ups those odds (to .74%). Docs usually don't recommend that DMD unless all other treatments have failed and even then its use is limited due to toxicity to the heart. It's a big gun that needs to be deployed carefully. As for liver damage, a known complication of some of the other DMDs, that damage is usually reversible and can largely be prevented with monitoring (which is essential). These side effects can't be overlooked and you bring up some good points.
              Dave Bexfield


              • #8
                I saw my neuro yesterday after my 2nd MRI results, and because of my new lesions and activity, my neuro was concerned and urged that I take either copaxone or tecfidera. What scares me about tecfidera is that it hasn't been tested for nearly as long as copaxone. It seems there's a trend in the human species to jump the gun on claiming safety before verifying longterm side effects. But of course, we are all eager for more effective treatments...
                From what I understood from my nurse, there doesn't seem to be any of the usual side-effects or risks (like liver damage) in tecfidera as we see in other DMDs, as long as white blood cell count is monitored. I/we could be wrong, I don't know. I'm eager to hear what others have to say about it, especially if they are taking it.



                • #9
                  Personally, im staying with Copaxone (just started in January). The long term results indicate that 2/3rds of people who stayed with it continuously for 15 years have not transitioned to SPMS and if you start at a lower EDSS score there is a much less likely chance of progression. I hear people claim the long term results are invalid since this phase is not placebo controlled but I don't think it is realistic (or humane) to have a 15 year placebo controlled trial.


                  For me the shots are no big deal so Im glad this is available to me.


                  • #10
                    If you live in Sacramento, CA and are interested in Tecfidera, there is an informational event sponsored by Biogen Idec coming up in September. I received a flyer in the mail this week. Here are the details:

                    September 12, 2013

                    5:00 pm (6:00 pm dinner)

                    Hilton Hotel
                    2200 Harvard Street
                    Sacramento, CA 95815

                    Call 1-866-539-8130


                    My Two Numb Feet - An MS Diary