April 22, 2024 News by Margarida Maia, PhD Viatris launches low-dose Copaxone generic formulation in Canada Viatris has launched a generic version of low-dose Copaxone (glatiramer acetate) in the Canadian market for the treatment of people with relapsing-remitting multiple sclerosis (RRMS) who retain the ability to walk. Called Glatiramer Acetate Injection 20 mg/mL, the product was approved in Canada as a generic of…
July 28, 2023 News by Margarida Maia, PhD Using Copaxone while breastfeeding safe for infants: Study Infants breastfed by mothers on Copaxone (glatiramer acetate) for relapsing forms of multiple sclerosis (MS) do not experience more adverse events, hospitalizations, or need more antibiotics for the first 1.5 years than those in the general infant population. That conclusion comes from new analyses of data from COBRA,…
April 18, 2023 News by Margarida Maia, PhD Vitamin D at high dose doesn’t lower MS relapse risk, Phase 3 trial finds A high-dose vitamin D supplement did not reduce the risk of relapses in people with relapsing-remitting multiple sclerosis (RRMS) already using a disease-modifying therapy to control disease activity, according to findings of a Phase 3 clinical trial. The VIDAMS study (NCT01490502) ā standing for Vitamin D…
December 8, 2022 News by Margarida Maia, PhD New Patent Filed for EmtinB With Copaxone as Potential MS Therapy NeuroScientific Biopharmaceuticals has filed a patent in Australia to protect the use of its lead candidate EmtinB in combination with Tevaās Copaxone (glatiramer acetate injection) as a potential treatment for multiple sclerosis (MS). The patent application (provisional number 2022903564) is based on data from a lab…
December 6, 2022 News by Patricia Valerio, PhD 2-year Copaxone Treatment in RRMS Found to Slow Loss of Gray Matter Two years of treatment with the approved therapy >Copaxone (glatiramer acetate) was found to slow the loss of cerebral gray matter and whole brain volume ā two markers of neurodegeneration ā in people with relapsing-remitting multiple sclerosis (RRMS). Notably, individuals on Copaxone…
September 26, 2022 News by Marisa Wexler, MS Pregnancy Risks Not Likely to Rise With Early DMT Use, Study Finds The rates of pregnancy complications are not higher in women with multiple sclerosis (MS) who were usingĀ disease-modifying therapies (DMTs) in the earliest stages of pregnancy, a study reported. The study, “Pregnancy outcomes after early fetal exposure to injectable first-line treatments, dimethyl fumarate or natalizumab in…
July 11, 2022 Columns by Ed Tobias MS News That Caught My Eye Last Week: COVID-19, Predicting Progression, Early Treatment, Estriol Higher COVID-19 Risk Tied to 2 MS Therapies, Even With Vaccination According to this study, people being treated with Ocrevus had 3.6 times the risk of a breakthrough COVID-19 infection compared with people being treated with most other disease-modifying therapies. For those treated with Gilenya, the risk was increased…
May 18, 2022 News by Marisa Wexler, MS Marriage, Education, DMT Affect Patients’ Treatment Adherence Among people with relapsing-remitting multiple sclerosis (RRMS), those who are married and have more formal education are more likely to take treatments as recommended, according to a new study from Iran. The study, “Effects of Disease-Modifying Treatments discontinuation in patients with Relapsing-Remitting Multiple Sclerosis: A 5…
May 16, 2022 News by Marta Figueiredo, PhD Copaxone Appears Safe for Infants Whose Mothers Breastfeed: Study TakingĀ Copaxone (glatiramer acetate), an approved therapy for relapsing forms ofĀ multiple sclerosisĀ (MS), while breastfeeding does not appear to be harmful to infants during their first 18 months, according to a real-life study in Germany called COBRA. āIn this study, we compared the development of 120 children in total, whose…
February 14, 2022 News by Marta Figueiredo, PhD EU Copaxone Label No Longer Advises Against Use During Breastfeeding The label of CopaxoneĀ (glatiramer acetate) ā an approved therapy for relapsing forms ofĀ multiple sclerosisĀ (MS) ā has been updated in Europe to no longer contain a warning against its use during breastfeeding. The label update follows a review by European Union health authorities of non-clinical and clinical evidence submitted…
February 3, 2022 News by Marisa Wexler, MS Self-injectable Therapies Tied to No Disease in 50% of Patients at 2 Years More than half of multiple sclerosis (MS) patients treated with self-injectable therapies ā namely, glatiramer acetate, marketed as Copaxone, among others, or any of a host of interferons ā showed no evidence of disease activity after two years, according to a study out of Turkey. Among patients treated for…
April 13, 2021 News by Patricia Inacio, PhD Phase 3 Trial of GA Depot as Monthly Relapsing MS Therapy Enrolling in US, Europe A Phase 3 trial investigating GA Depot, a long-acting, once-a-month injectable formulation of glatiramer acetate, is seeking patients with relapsing forms of multiple sclerosis (MS). The global study (NCT04121221) aims to include 960 adults, ages 18 to 55, diagnosed withĀ clinically isolated syndromeĀ (CIS),Ā relapsing-remitting…
April 9, 2021 News by Marta Figueiredo, PhD Overall Cost of DMTs Stable 2018ā2020, Study Finds The overall cost of disease-modifying therapies for multiple sclerosis (MS) in the U.S. remained stable from 2018 to 2020, according to pharmacy and medical claims data from Prime Therapeuticsā insured members. This stabilization derived from a balance between a reduction in Copaxone (glatiramer acetate injection) use due…
February 10, 2021 News by Forest Ray PhD Trial to Examine if Ocrevus Eases Cognitive Fatigue in RRMS Researchers at the Kessler Foundation, with support from Genentech, are opening a study into howĀ Ocrevus (ocrelizumab) affects cognitive fatigue ā the feeling of complete exhaustion after focused concentration ā in people with relapsing-remitting multiple sclerosis (RRMS). Cognitive fatigue is a frequent problem with MS, reported in…
October 21, 2020 News by Diana Campelo Delgado NanoStilbene Better Than Copaxone at Reducing MS Symptoms in Mouse Model The nutritional supplement NanoStilbene, developed by Therapeutic Solutions International, worked better to reduce neurological damage and disease symptoms in an animal model of multiple sclerosis (MS) than the market-leading MS therapy Copaxone, the company announced. NanoStilbene is composed of easily absorbed nano-particles of pterostilbene, a…
August 25, 2020 News by Patricia Inacio, PhD Mavenclad Effectively Lowers Relapse Rates, Study Comparing DMTs Finds MavencladĀ (cladribine) appears to be better at lowering relapse rates during the first two years of disease in relapsing-remitting multiple sclerosis (RRMS) patients than other MS therapies, including interferon, Copaxone (glatiramer acetate) and Tecfidera (dimethyl fumarate), a head-to-head observational study found. Mavenclad, however, was less effective at…
August 14, 2020 News by Forest Ray PhD 35% of Newly Diagnosed Patients Given DMT in Follow-up Years, US Study Finds Almost two-thirds of people newly diagnosed with multiple sclerosis (MS) in the United States, identified through a national database, were not prescribed disease-modifying therapies (DMTs) over an average of more than two years of follow-up, a real-world study of nearly 5,700 patients found. Current guidelines “recommend early treatment with…
July 16, 2020 News by Marta Figueiredo, PhD NeuroScientific Biopharmaceuticals’ Lead Candidate, EmtinB, Shows Promise in Preclinical Model of MS NeuroScientific Biopharmaceuticals (NSB)ās lead candidate EmtinBĀ induces significantly greaterĀ myelin regeneration in a cellular model ofĀ multiple sclerosisĀ (MS) than the market-leading therapyĀ Copaxone, the company announced. āThese results represent a potential breakthrough in the treatment of MS as there are currently no approved therapeutic drugs available to patients that…
May 26, 2020 Columns by Ed Tobias MS News that Caught My Eye Last Week: Vascular Disease, Glatopa vs. Copaxone, Exercise Tips, MS App Higher Risk of Vascular Disease Among MS Patients in the UK, Population-based Study Reveals You’d think that people with multiple sclerosis (MS) would be likely to have vascular disease due to the sedentary lifestyles many of us lead. But this large, lengthy study that looks at the records of…
May 20, 2020 News by Marisa Wexler, MS Glatopa Shows Efficacy Similar to Copaxone, Study in Real-world Use Finds Glatopa, a generic form ofĀ Copaxone, is as effective as the brand-name medication in terms of disease outcomes and has similar healthcare-related costs in real-world use in patients with relapsingĀ multiple sclerosis (MS), a new U.S. study suggests. Data also suggest a trend toward lower relapse rates with Glatopa…
February 17, 2020 Columns by Ed Tobias MS News that Caught My Eye Last Week: Report on Ocrevus Use, Cognitive Decline in MS, Gold Nanocrystals and Remyelination Study Ocrevus Use Rises Among New Starters with RRMS, Loses Ground to Other Therapies in PPMS Ocrevus (ocrelizumab) bolted out of the starting gate after it was approved for use in the U.S. about three years ago. However, though its use by people with relapsing forms of multiple sclerosis continues…
November 22, 2019 News by Ana Pena PhD Ocrevus Top Choice of US Neurologists for Active SPMS, But Mayzent and Mavenclad Gaining Interest, Report Says Genentech‘sĀ OcrevusĀ (ocrelizumab) continues to be the most prescribed medication to reduce inflammatory disease in people with active secondary progressive multiple sclerosisĀ (SPMS) amongĀ U.S. neurologists, even though Novartis’Ā MayzentĀ (siponimod) and EMD Serono’sĀ MavencladĀ (cladribine) were approved in March to treat this same MS…
September 20, 2019 Columns by Ed Tobias Neuros Say that Flu Shots and Other Vaccines Are OK for Those with MS This is the time of year when my wife and I start thinking about getting our flu shots. We’ve already had the pneumonia and the older shingles vaccine and hope to soon update with the new shingles vaccine, Shingrix (recombinant zoster vaccine). These vaccines are OK with my neurologist and…
August 30, 2019 Columns by Ed Tobias Another Study Shows That Costs of Disease-modifying Therapies Are Zooming It probably comes as no surprise to you that the costs of some of the most popular MS medications have been soaring. A new study by researchers at the University of Pittsburgh reports that their list prices have more than quadrupled in a decade. And out-of-pocket costs rose even more.
August 21, 2019 News by Ana Pena PhD Gilenya, Aubagio, Tysabri, Tecfidera Dominate MS Therapy Switches in Europe, Spherix Survey Finds Novartis‘ Gilenya (fingolimod), Sanofi Genzyme‘sĀ Aubagio (teriflunomide), andĀ BiogenāsĀ TysabriĀ (natalizumab) and Tecfidera (dimethyl fumarate) are the top disease-modifying therapies to which patients with multiple sclerosis (MS) have most frequently switched in…
May 16, 2019 News by Jose Marques Lopes, PhD #AANAM – Gilenya at 0.5 mg Superior to Copaxone at Lowering Relapses, Phase 3 Trial Shows Oral Gilenya (fingolimod) taken daily at a 0.5 mg dose is superior toĀ Copaxone (glatiramer acetate) injections at lowering relapses and disease activity over one year in patients with relapsing-remitting multiple sclerosis (RRMS), according to results of a Phase 3b trial. The research, āEfficacy and Safety…
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."
January 29, 2019 Columns by Ed Tobias New Study Supports Hitting MS Fast and Hard The question of how quickly to start a disease-modifying therapy (DMT) after a multiple sclerosis (MS) diagnosis is one that I frequently see when I browse online. It goes hand in hand with questions about which DMT is best to start with. There are many things to consider when…
December 11, 2018 News by Santiago Gisler Glatect Added to Public Drug Plan in British Columbia as Sole RRMS Treatment of Its Type Pendopharmās Glatect (glatiramer acetate) ā a treatment for patients with relapsing-remitting multiple sclerosis (RRMS) ā has been added to the public drug plan in the Canadian province of British Columbia, and is now the only glatiramer-based treatment for RRMS patients there using the plan. After Copaxone…