Treatment during pregnancy with the approved multiple sclerosis (MS) medication Copaxone (glatiramer acetate injection) does not appear to increase the risk of birth defects in infants, and its use while breastfeeding is not linked to growth problems in the youngsters, according to follow-up data of mothers and their children…

The European Commission (EC) fined Teva Pharmaceuticals €462.6 million — more that $502 million — after an investigation it launched found the company illegally tried to stop competitor versions of Copaxone (glatiramer acetate injection), its blockbuster drug for multiple sclerosis (MS), from entering markets. Several patents…

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…

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,…

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) — standing for Vitamin D…

NeuroScientific Biopharmaceuticals has filed a patent in Australia to protect the use of its lead candidate EmtinB in combination with Teva’s 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…

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 — two markers of neurodegeneration — in people with relapsing-remitting multiple sclerosis (RRMS). Notably, individuals on Copaxone…

The rates of pregnancy complications are not higher in women with multiple sclerosis (MS) who were using 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…

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…

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…

Taking Copaxone (glatiramer acetate), an approved therapy for relapsing forms of multiple sclerosis (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. “In this study, we compared the development of 120 children in total, whose…

The label of Copaxone (glatiramer acetate) — an approved therapy for relapsing forms of multiple sclerosis (MS) — 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…

More than half of multiple sclerosis (MS) patients treated with self-injectable therapies — namely, glatiramer acetate, marketed as Copaxone, among others, or any of a host of interferons — showed no evidence of disease activity after two years, according to a study out of Turkey. Among patients treated for…

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 with clinically isolated syndrome (CIS), relapsing-remitting…

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 Therapeutics’ insured members. This stabilization derived from a balance between a reduction in Copaxone (glatiramer acetate injection) use due…

Researchers at the Kessler Foundation, with support from Genentech, are opening a study into how Ocrevus (ocrelizumab) affects cognitive fatigue — the feeling of complete exhaustion after focused concentration — in people with relapsing-remitting multiple sclerosis (RRMS). Cognitive fatigue is a frequent problem with MS, reported in…

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…

Mavenclad (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…

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…

NeuroScientific Biopharmaceuticals (NSB)’s lead candidate EmtinB induces significantly greater myelin regeneration in a cellular model of multiple sclerosis (MS) than the market-leading therapy Copaxone, the company announced. “These results represent a potential breakthrough in the treatment of MS as there are currently no approved therapeutic drugs available to patients that…

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…

Glatopa, a generic form of 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 relapsing multiple sclerosis (MS), a new U.S. study suggests. Data also suggest a trend toward lower relapse rates with Glatopa…

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…

Genentech‘s Ocrevus (ocrelizumab) continues to be the most prescribed medication to reduce inflammatory disease in people with active secondary progressive multiple sclerosis (SPMS) among U.S. neurologists, even though Novartis’ Mayzent (siponimod) and EMD Serono’s Mavenclad (cladribine) were approved in March to treat this same 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…

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.

Novartis‘ Gilenya (fingolimod), Sanofi Genzyme‘s Aubagio (teriflunomide), and Biogen’s Tysabri (natalizumab) and Tecfidera (dimethyl fumarate) are the top disease-modifying therapies to which patients with multiple sclerosis (MS) have most frequently switched in…

Oral Gilenya (fingolimod) taken daily at a 0.5 mg dose is superior to 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, “Efficacy and Safety…

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…

Treating 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 — 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 of Tecfidera (by Biogen) for people with relapsing-remitting forms of the disease. However, their complete mechanism of action remains unclear. Aiming to address this gap, scientists at the Advanced Science Research Center (ASRC) at The Graduate Center of The City University of New York and the 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) — marketed as Copaxone by Teva Pharmaceuticals, with generic forms by Sandoz (as Glatopa) and by Mylan. All patients had stable disease for at least three months, but disease duration was shortest in untreated patients — 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 typically have an activated form 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, treatment 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 — the addition of methyl groups — in T-cells containing CD4, compared to glatiramer acetate. Specifically, this overmethylation was observed in a micro-RNA — tiny RNA molecules than control gene expression — 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 been implicated in MS. The epigenetic effects of FAEs were subsequently validated by comparing pre- to post-treatment with Tecfidera in seven patients. In turn, in vitro (lab dish) experiments showed that FAEs act specifically on the activation of naïve T-cells — those able to respond to new pathogens to the immune system — 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 study’s 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 study’s senior author, concluded: "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."