June 23, 2020 News by InĆŖs Martins, PhD US Court Rules in Favor of Mylan, Generic Version of Tecfidera Generic formulations of dimethyl fumarateĀ ā currently sold as Tecfidera by BiogenĀ ā were given a green light to enter the U.S. market, after a federal courtĀ invalidated a patent protecting Tecfidera from generic competition as aĀ multiple sclerosisĀ (MS) treatment.Ā The ruling by the District Court for the…
May 20, 2020 News by Marisa Wexler, MS Biogen Presents Update on its MS Therapeutic Portfolio Biogen has released new data on several of its therapies for multiple sclerosis (MS), including Vumerity (diroximel fumarate), Tecfidera (dimethyl fumarate), and Tysabri (natalizumab). The data ā six presentations ā originally were to be presented at the 2020 annual conference of the American…
May 5, 2020 News by Steve Bryson, PhD FDA Approves Bafiertam, Tecfidera Bioequivalent, for Relapsing MS The U.S. Food and Drug Administration (FDA) has given final approval toĀ Banner Life Sciencesā Bafiertam (monomethyl fumarate),Ā a bioequivalent alternative to Biogenās Tecfidera (dimethyl fumarate) to treat people with relapsing…
April 14, 2020 News by Marta Figueiredo, PhD Ocrevus Use Still Growing in Europe But Challenges on Horizon, Spherix Reports Prescriptions ofĀ RocheāsĀ OcrevusĀ (ocrelizumab) among multiple sclerosis (MS) patients initiating or switching aĀ disease-modifying therapy (DMT) continue to rise in Europe, according toĀ a surveyĀ conducted byĀ Spherix Global Insights. Ocrevus, an anti-CD20 monoclonal antibody administered directly into a vein,Ā was approved in the European UnionĀ to treat active forms…
October 24, 2019 News by Ana Pena PhD Potential RRMS Fumarate Treatment Free of ‘Flush’ Effect to Enter Trial in 2020, Vitalis Says VitalisĀ is planning to open a pivotal clinical trial into its new formulation of fumarate, calledĀ VTS-72, that has shown promise in easing flushing ā a common and troublesome side-effect of Tecfidera (dimethyl fumarate), an oral treatment for relapsing-remitting multiple sclerosis (RRMS). The company announced plans to…
March 19, 2019 Columns by Ed Tobias DMT Choice for Your MS Is Your Decision About 15 disease-modifying therapies (DMTs) are available to treat MS these days. So, choosing which to use can be daunting. I’ve been treated with four DMTs since I was first prescribed Avonex (interferon beta-1a) back in 1996. Each time I’ve switched treatments, my neurologist has suggested a number of…
March 11, 2019 News by Jose Marques Lopes, PhD Tecfidera May Work to Lower Relapses by Inducing Epigenetic Changes in T-cells, Study Suggests TreatingĀ multiple sclerosis with Tecfidera induces specific genetic alterations that may reduce the levels of immune T-cells targeting the central nervous system, researchers report. Environmental stimuli may induce epigenetic changes in cells ā meaning not alterations in the genes themselves, but changes in gene expression (the process by which information in a gene is synthesized to create a working product, like a protein). Epigenetic changes may induce MS development, as these alterations can cause T-cells to attack the central nervous system. One type of epigenetic change is DNA demethylation, the removal of methyl chemical groups, in which molecules involved in metabolism (such as fumarate) interact with enzymes known as DNA demethylases. This process in key for T-cell activation, function and memory, suggesting that it could be an immunomodulatory target. Fumaric acid esters were shown to be effective in MS clinical trials, leading to the approval ofĀ Tecfidera (by Biogen) for people with relapsing-remitting forms of the disease.Ā However, their complete mechanism of action remains unclear. Aiming to address this gap, scientists at theĀ Advanced Science Research Center (ASRC) at The Graduate Center of The City University of New YorkĀ and theĀ Icahn School of Medicine at Mount Sinai, recruited 98 MS patients, either previously untreated (47 people, mean age of 38.4), treated with Tecfidera (35 people, mean age of 42.3), or treated with glatiramer acetate (16 patients, mean age of 43.4) ā marketed asĀ CopaxoneĀ byĀ Teva Pharmaceuticals, with generic forms byĀ SandozĀ (asĀ Glatopa) and byĀ Mylan. All patients had stable disease for at least three months, but disease duration was shortest in untreated patients ā 40.4 months vs. 130 months in those given Tecfidera, and 100 months in patients using glatiramer acetate. Blood samples were collected from each participant to assess epigenetic changes in T-cells expressing the cell surface marker CD4. MS patients typicallyĀ have an activated formĀ of these cells in their blood and cerebrospinal fluid, the liquid surrounding the brain and spinal cord. Results revealed that, compared to the other two groups,Ā treatmentĀ with Tecfidera was associated with a lower percentage of T-cells containing the CD3, CD4, and CD8 markers, as well as lower levels of subsets of T-cells expressing the CCR4 and CCR6 receptors, which are critical to T-cell migration to the gut, brain, and skin. Treatment with glatiramer acetate resulted in significantly milder alterations in T-cell percentages compared to no treatment. Researchers then found that FAEs induce excessive methylation ā the addition of methyl groups ā in T-cells containing CD4, compared to glatiramer acetate. Specifically, this overmethylation was observed in a micro-RNA ā tiny RNA molecules than control gene expression ā known as miR-21, key for the differentiation of a subset of T-cells called T helper-17 (Th17) cells and for CCR6 expression in MS mouse models. These Th17 cells are critical in tissue inflammation and destruction, and have beenĀ implicatedĀ in MS. The epigenetic effects of FAEs were subsequently validated by comparing pre- to post-treatment with Tecfidera in seven patients. In turn, in vitroĀ (lab dish) experiments showed that FAEs act specifically on the activation of naĆÆve T-cells ā those able to respond to new pathogens to the immune system ā containing the CD4 or the CD8 markers. Of note, patients with MS have shown increased miR-21 levels, particularly during acute relapses. As such, the team hypothesized that its hypermethylation by FAEs could contribute to remission and the prevention of relapses in this patient population. These results "suggest that the metabolic-epigenetic interplay in T-cells could be harnessed for therapeutic purposes," the researchers wrote, and that the immunomodulatory effect of FAEs in MS is due at least in part to the epigenetic regulation of T-cells. The researchers believe that their findings have a broader implication, beyond MS. "Our findings about therapeutically active metabolites have implications for the treatment of not only multiple sclerosis but also other autoimmune diseases, such as psoriasis and inflammatory bowel disease, which involve the same type of T-cells," Achilles Ntranos, the studyās lead author, said in a press release. "Understanding the epigenetic effect of metabolites on the immune system will help us develop several novel strategies for the treatment of autoimmune diseases, which could help patients and physicians achieve better clinical outcomes," Ntranos added. Patrizia Casaccia, the studyās senior author, concluded:Ā "It may one day be possible to target and suppress production of the specific brain-homing T-cells that play a role in the development of MS."
February 25, 2019 Columns by Ed Tobias MS News that Caught My Eye Last Week: Early DMT Use, Aubagio vs. Tecfidera, Lipoic Acid Study, MS Forums Early Use of High-efficacy DMTs of Long-term Benefit to MS Patients, Real-world Study Reports The question of whether to start treating multiple sclerosis (MS) with an older, less effective disease-modifying therapy (DMT) and then move to a more effective one ā or use a heavy-hitting medication right…
February 20, 2019 News by Patricia Inacio, PhD Early Use of High-efficacy DMTs of Long-term Benefit to MS Patients, Real-world Study Reports Multiple sclerosis (MS) patients given intensive disease-modifying therapies early in their disease course have more favorable long-term outcomes than those treated with an escalating regimen, real-world data shows. The study, āClinical Outcomes of Escalation vs Early Intensive Disease-Modifying Therapy in Patients With Multiple Sclerosis,ā was published in the journalĀ …
October 5, 2018 Columns by Ed Tobias Could Government Probe Threaten Pharma Patient Assistance Programs? Many of us have received help to pay for our MS medications. Now there’s a chance that assistance could be threatened. A recent article in the The Wall Street Journal reports that U.S. government prosecutors are looking into whether some pharmaceutical companies’ patient assistance programs are on the wrong…
June 13, 2018 News by Vijaya Iyer, PhD Effectiveness of Gilenya and Tecfidera Compared in Real-World Study in Italy Gilenya (fingolimod) and Tecfidera (dimethyl fumarate) are equally effective as first-line treatments in people with relapsing-remittingĀ multiple sclerosis (RRMS), but Gilenya may be of slightly more benefit to those who switch from a previous injectable therapy, according to a real-world study of patients in Italy. The study, “…
February 8, 2018 Columns by Tamara Sellman The MS Alphabet: Plaquenil, PML, Prevalence, and Other ‘P’ Words (Part 6 of 7) Editorās note: Tamara Sellman continues her occasional series on the “MS alphabet” with this column referencing terms starting with the letter “P.” This post comes sixth in a series of seven. Symptoms of MS Progressive multifocal leukoencephalopathy (PML) Though progressive multifocal leukoencephalopathy (PML) isnāt an actual symptom of MS,…
January 17, 2018 News by Ana Pena PhD Majority of RRMS Patients in Swedish Study Seen to Stop Using Tecfidera Within 2 Years A majority of relapsing-remitting multiple sclerosis (RRMS) patients at a Swedish clinic who initiated treatment with Tecfidera (dimethyl fumarate; DMF) either stopped or switched to another therapy within two years, a study reports. Researchers in the observational study were not able to determine exact reasons for discontinuation. But, they wrote,…
November 29, 2017 News by Alice MelĆ£o, MSc Alkermes, Biogen Partnering on Therapy for Relapsing Forms of Multiple Sclerosis AlkermesĀ and BiogenĀ have begun working together on a compound known asĀ ALKS 8700Ā as a potential treatment for relapsing forms of multiple sclerosis. Under the agreement, Alkermes will be responsible for obtaining regulatory approval of the drug, while Biogen will handle its marketing. ALKS is taken orally. The body quickly transforms it into a compound known as monomethyl fumarate that can counter MS. Aikermes designed it to have better features thanĀ Tecfidera (dimethyl fumarate)Ā ā in particular, fewer gastrointestinal side effects. The partnership gives Biogen worldwide marketing rights to ALKS 8700. Alkermes will receive a royalty on global sales. Aikermes is evaluating ALKS 8700's safety and effectiveness in what it has dubbed the EVOLVE-MS clinical trial program. It includes two Phase 3 trials that are comparing ALKS 8700 with Tecfidera in patients with relapsing-remitting MS, or RRMS. Preliminary results of the EVOLVE-MS-1 trial, which involved 580 patients, showed few gastrointestinal side effects from ALKS 8700. The most common adverse events in the first month of treatment were flushing, diarrhea, and a rash known as pruritus. Aikermes discussed the treatments safety, and patients' ability to tolerate it, at the 7th Joint ECTRIMS-ACTRIMS MeetingĀ in Paris in October. The company is still recruiting participantsĀ for a second trial that will compare ALKS 8700 and Tecfidera's effect on the gastrointestinal system. The EVOLVE-MS-2 study will Ā be conducted at locations in several U.S. states and six sites in Poland. Alkermes expects to release initial findings from the trial in the first half of 2018. Ā
November 8, 2017 News by Patricia Silva, PhD Global Phase 3 Trial of Oral Ponesimod Plus Tecfidera Enrolling Relapsing MS Patients Actelion is recruiting about 600 relapsing multiple sclerosis (MS) patients to a Phase 3 trial testing the addition of oral ponesimod to Tecfidera (dimethyl fumarate)Ā in people who continue experiencing relapses while on the treatment. Ponesimod works in a similar way to Novartisā Gilenya (fingolimod) ā making immune…
November 1, 2017 News by Alice MelĆ£o, MSc #MSParis2017 ā EVOLVE-MS-1 Interim Trial Data Shows Alkermes Therapy Safe for Treating Relapsing MS Preliminary data from the Phase 3 EVOLVE-MS-1 trial shows thatĀ ALKS 8700Ā ā an investigative therapy developed byĀ AlkermesĀ to treat relapsing forms of multiple sclerosis ā has a good safety and tolerability profile. ALKS 8700 is an oral compound. Once inside the body, it is rapidly transformed into the therapeutic compound monomethyl fumarate (MMF). Although similar, this drug candidate was designed to offer features different than those achieved with the commercially available Tecfidera (dimethyl fumarate). Alkermes is currently assessing the safety and efficacy of ALKS 8700 in the EVOLVE-MS program, which includes two Phase 3 clinical trials in patients with relapsing-remitting MS. The EVOLVE-MS-1 is a two-year study being conducted in 107 U.S. and European research sites. It will evaluate the long-term safety of ALKS 8700 in some 930 RRMS patients. Interim data collected during the first month of treating 580 participants showed low incidence of GI adverse events, with no reports of serious events. The most common adverse side effects associated with the treatment were flushing, pruritus and diarrhea. Alkermes, which is based in Ireland, said additional results from the initial three months of treatment further supported the positive safety data of ALKS 8700, with only 2.3 percent of patients reporting serious adverse events and 3.7 percent having to stop treatment. The EVOLVE-MS-2 trial, being conducted at 48 U.S. sites, will compare the safety and efficacy of ALKS 8700 versus Tecfidera in RRMS patients. The study is still recruiting participants. Recent data of EVOLVE-MS-2 was also subject of a poster presentation at the ECTRIMS-ACTRIMS Meeting.
October 20, 2017 News by Patricia Silva, PhD #MSParis2017 – Alkermes to Give Updates on ALKS 8700 Studies at ECTRIMS-ACTRIMS Meeting Alkermes will showcase its work in developing a treatment that harnesses the effect of Tecfidera (dimethyl fumarate) for relapsing multiple sclerosis (MS), while lowering the risk of stomach problems at the 7th Joint ECTRIMS-ACTRIMS Meeting this month in Paris. The investigational drug, ALKS 8700, uses the same mechanism of action as Tecfidera. By building the molecule in a different way, however, the company expects it will show better tolerability. Once in the body, dimethyl fumarate turns into monomethyl fumarate (MMF), the molecule that actually impacts MS disease processes. But before giving rise to MMF,Ā dimethyl can cause side effects in users, particularly gastrointestinal. In fact, stomach problem were what causedĀ people in Tecfidera Phase 3 trials to stop the treatment. Alkermes uses a so-called prodrug approach to try to overcome this problem. By attaching a different compound to MMF āĀ which breaks away from the molecule once in the body ā Ā it is possible to deliver MMF with lesser gastrointestinal side effects, Phase 1 study data indicate. At the meeting, the company will present two posters on two clinical trials exploring ALKS 8700 in patients with relapsing-remitting MS. The first presentation, will describe a Phase 3 trial that aims to compare ALKS 8700 to Tecfidera in about 420 patients. The trial is primarily concerned with the drugās safety, and will measure the occurrence and impact of gastrointestinal side effects in the two treatment groups. The presentation will only include descriptions of patients characteristics and study design, as outcomes are yet to be analyzed. Patients who complete the Phase 3 trial will be eligible to continue in an ongoing open-label, long-term safety study, called EVOLVE-MS-1, covered in the companyās second presentation. By March 3, 2017, the study had enrolled 543 patients. In addition to describing patient characteristics, researchers will present the rates of discontinuation caused by gastrointestinal adverse events within one month of starting the treatment.
August 31, 2017 News by Alice MelĆ£o, MSc Tecfidera Shows Promise as Replacement MS Therapy for Tysabri, Study Shows Tecfidera (dimethyl fumarate) can be a suitable replacement therapy whenĀ Tysabri (natalizumab) is discontinued, keeping low levels of disease activity in patients with relapsing-remitting multiple sclerosis (RRMS), according to a report published in theĀ Journal of Neurology, Neurosurgery & Psychiatry. Several studies have demonstrated the effectiveness and…
August 28, 2017 News by Alice MelĆ£o, MSc RRMS Patients Needed for Phase 3 Trial to Assess Adverse GI Effects of ALKS 8700 Therapy vs. Tecfidera AlkermesĀ is funding a Phase 3 clinical trial evaluating the effects of itsĀ ALKS 8700Ā therapyĀ on the gastrointestinal tracts of relapsing-remitting multiple sclerosis (RRMS) patients,Ā compared toĀ Tecfidera (dimethyl fumarate), according to a news release by the National Multiple Sclerosis Society. ALKS 8700,Ā an orally administrated form of monomethyl fumarate, is still…
June 23, 2017 News by Janet Stewart, MSc Tecfidera Improves MS Patients’ Work Productivity, Compared with Other Therapies, Study Shows Multiple sclerosis patients taking Tecfidera, or dimethyl fumarate, were more productive at work than those on Copaxone or beta-interferon therapies, according to a study. Tecfidera also increased patients’ quality of life, researchers said. The study covered patients with relapsing-remitting multiple sclerosis, or RRMS. The four beta-interferon treatments wereĀ Avonex, Betaseron, Rebif,…
April 25, 2017 News by Patricia Silva, PhD Latest Tecfidera and Tysabri Data Suggest Treatments Improve MS Outcomes When Used Early Real-world data of treatment with Tecfidera (dimethyl fumarate) and Tysabri (natalizumab) in relapsing multiple sclerosis (MS) patients suggest that treatment at early disease stages improves outcomes and prevents disability development. The studies, presented by Biogen at the American Academy of Neurology 2017 Annual MeetingĀ in Boston, might challenge the…
April 20, 2017 News by Alice MelĆ£o, MSc Early Use of Tecfidera and Tysabri Improves MS Patients’ Outcomes, Studies Suggest The latest results on Tecfidera (dimethyl fumarate) and TysabriĀ (natalizumab) use in a clinical practice setting suggest that early treatment can improve outcomes in multiple sclerosis (MS) patients. This and other recent dataĀ on Tecfidera and Tysabri for the treatment of MS will be presented by BiogenĀ at the…
January 17, 2017 News by Ćzge Ćzkaya, PhD Tecfidera Seen to Potentially Limit Vision Problems in MS Genetically silencing the transcription factor Nrf2 in a mouse model of multiple sclerosis (MS) results in visual deficits, inflammation of the optic nerve, and degeneration of the retinal ganglion cells (RGC), according to a study published in the scientific journal Molecular Vision.
October 3, 2016 News by Patricia Silva, PhD Phase 3 Study to Test Oral Combination, Tecfidera and Ponesimod, to Treat Relapsing MS ActelionĀ announced that it will investigate the therapeutic potential of a new, oral combination therapy with ponesimod andĀ Tecfidera (dimethyl fumarate) asĀ a treatment for relapsing multiple sclerosis (RMS). The Phase 3 clinical study, being conducted underĀ a Special Protocol Assessment agreement with the U.S. Food and Drug Administration (FDA), aims to find…
September 27, 2016 News by Patricia Silva, PhD How Tecfidera Works to Reduce MS Relapses Finally Discovered, May Lead to Better Treatments How the multiple sclerosis (MS) therapyĀ Tecfidera (dimethyl fumarate) works on a molecular levelĀ hasĀ finally beenĀ uncovered,Ā using a new method that can map a drugās protein targets. The insights gainedĀ may open up new avenues for the development of more specific drugs, based on the same mechanisms, but with fewer side effects. The study,…
August 12, 2016 News by Patricia Inacio, PhD Researchers Reveal Mechanism of Action for Tecfidera, an MS Therapy Researchers found the molecular target of the multiple sclerosis (MS)-approved drug Tecfidera, (dimethyl fumarate or DMF), unveiling the mechanism associated with the drug’s anti-inflammatory action. The study, āDimethyl fumarate blocks pro-inflammatory cytokine production via inhibition of TLR induced M1 and K63 ubiquitin chain formation,ā was…
July 5, 2016 News by Katie McCallum Latest Findings on RRMS Oral Therapy Tecfidera (Dimethyl Fumarate) Detailed in New Report Since its approval by the U.S. Food and Drug Administration (FDA) in 2013,Ā TecfideraĀ (dimethyl fumarate) has emerged as a first-line treatment for relapsing-remitting multiple sclerosis (RRMS), the most common form of multiple sclerosis (MS). While two separate clinical trials demonstrated Tecfidera’s ability to significantly reduce both the rate of relapse…
June 6, 2016 News by Patricia Inacio, PhD #CMSC16 – Delayed-release Dimethyl Fumarate Benefits Newly Diagnosed MS Patients, According to Study Newly diagnosed patients with relapsing-remitting multiple sclerosis (RRMS) show significant improvements when treated with delayed-release dimethyl fumarate (DMF), especiallyĀ in terms of reduction inĀ confirmed disability progression. The study, āEfficacy of Delayed-Release Dimethyl Fumarate in Newly Diagnosed Patients with Multiple Sclerosis Using a Composite Measure of Disability,ā was recently presented at the…
May 13, 2016 News by admin Dimethyl Fumarate, a Common MS Drug, Found to Work Independently of Nrf2 Pathway AĀ commonly prescribed multiple sclerosis (MS) medication may act to modulate the immune system. The finding is describedĀ in the articleĀ “Dimethyl fumarate treatment induces adaptive and innate immune modulation independent of Nrf2,“Ā published in Ā the journalĀ Proceedings of the National Academy of Sciences. MS develops due to an…
April 20, 2016 News by admin Biogen Releases New Data Showing Effectiveness of Tecfidera in Newly Diagnosed MS Patients at AAN 2016 BiogenĀ reported new data describing the effectiveness of TecfideraĀ (dimethyl fumarate) in newly diagnosed relapsing-remitting multiple sclerosis (RRMS) patients in a recent presentation at the 68th annual meeting of the American Academy of Neurology (AAN). The conference, taking placeĀ in Vancouver, Canada, runs through April 21. Tecfidera is an…