August 8, 2023 News by Lindsey Shapiro, PhD FDA decision on GA Depot for relapsing MS expected March 2024 The U.S. Food and Drug Administration (FDA) has agreed to review Viatris and Mapi Pharma‘s application seeking approval of GA Depot for the treatment of relapsing forms of multiple sclerosis (MS). The medication is a long-acting formulation of glatiramer acetate, the active ingredient in the approved…
March 13, 2023 News by Andrea Lobo, PhD WHO asked to add 3 MS treatments to its list of ‘essential medicines’ Aiming to promote equitable accessĀ toĀ multiple sclerosis (MS) treatments worldwide, an international MS alliance is asking that threeĀ disease-modifying therapies (DMTs) be added to the World Health Organization’s (WHO) list of essential medicines. Inclusion on the WHO list is considered an important if “initial” step in assuring that helpful treatments…
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 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…
December 7, 2021 News by Marisa Wexler, MS Worsening of Disability Evident in Older Patients Who Stop DMTs While older multiple sclerosis (MS) patients whose conditions are stable commonly stop using disease-modifying therapies (DMTs), a study indicates this decision can shortly lead toĀ a marked disease worsening in a substantial portion of them. “Our results raise important questions about the accepted practice of discontinuing medications once MS…
October 13, 2021 News by Marisa Wexler, MS #ECTRIMS2021 ā Rituximab as First RRMS Therapy Outperforms Others Editorās note: TheĀ Multiple Sclerosis News Today team is providing in-depth coverage of the virtual 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), Oct. 13ā15. GoĀ here to see the latest stories from the…
December 2, 2020 News by Joana Carvalho, PhD Tecfidera May Be Effective Option for Relapsing MS Patients Who Fail to Respond to Glatiramer Acetate Tecfidera (dimethyl fumarate) may be an effective treatment option for patients with early relapsing forms of multiple sclerosis (MS) who fail to respond adequately to glatiramer acetate, according to a post-hoc analysis of an observational study. The findings were reported in an article, āEffectiveness…
September 24, 2020 News by Marta Figueiredo, PhD Older Age at DMT Discontinuation Linked to Sustained NEDA in CIS Patients Older age at disease-modifying therapy (DMT) discontinuation is the main predictive factor of sustained “no evidence of disease activity” (NEDA) in people starting DMT immediately after being diagnosed with clinically isolated syndrome (CIS), according to a study in Austria. In particular, patients discontinuing DMT at age 45 or…
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 6, 2020 News by Marta Figueiredo, PhD Tecfidera Safe and Effective in Hispanic/Latino MS Patients, Real-world Data Show TecfideraĀ (dimethyl fumarate) is as safe and effective in Hispanic/LatinoĀ multiple sclerosisĀ (MS) patients as it is in their non-Hispanic and non-Latino peers, three-year data from a real-world study show. These interim findings, based on the largest group of Tecfidera-treated Hispanic and Latino MS patients studied to date, support the therapyās…
June 17, 2020 News by Joana Carvalho, PhD Phase 3 Trial of GA Depot for Relapsing MS Advances With $20M Support Mapi Pharma, supported by an additionalĀ $20 million investment from its partner Mylan, will continue a Phase 3 trial assessing the safety, tolerability, and efficacy of GA Depot, its long-acting, once-a-month injectable formulation of glatiramer acetate. The study (NCT04121221),Ā which opened in October 2019,…
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 14, 2020 News by Ana Pena PhD Ocrevus Use Rises Among New Starters with RRMS, Loses Ground to Other Therapies in PPMS First-line use of Genentech‘s Ocrevus (ocrelizumab) for patients with multiple sclerosis (MS) has remained stable through 2019 compared to 2018, according to the latest Spherix Global Insights‘ report. However, the latest edition of “RealWorld Dynamix: DMT New Starts in Multiple Sclerosis (US),” based…
November 1, 2019 News by Ana Pena PhD Interferons Superior to Glatiramer Acetate, and Tysabri More Effective than Gilenya for RRMS, Real-world Study Finds Interferon therapy (brand names Avonex, Betaseron, and others) is more effective than glatiramer acetate (sold as Copaxone, Glatopa and other generics) for reducing relapses…
October 30, 2019 News by Alice MelĆ£o, MSc First Relapsing MS Patient Enrolled in Phase 3 Trial of Mapi Pharmaās Once-monthly Glatiramer Formulation A new Phase 3 clinical trial to explore the safety and efficacy of Mapi Pharmaās once-a-month injectable formulation of glatiramer acetate ā named GA Depot ā has started enrolling patients with relapsing multiple sclerosis (MS). The trial (NCT04121221) is expected to enroll approximately 960 participants, 18 to 55…
October 18, 2019 News by Ana Pena PhD #ECTRIMS2019 – Are Injectables Inappropriate for Active Relapsing MS Treatment? With more high-efficacy therapies becoming available, is it now inappropriate to prescribe older injectables ā interferon beta and glatiramer acetate ā to people with active relapsing multiple sclerosis (MS)? This question was at the core of what was called a “burning debate” at this year’s European Committee…
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…
September 9, 2019 News by Alice MelĆ£o, MSc #ECTRIMS2019 – Mapi Pharma to Detail Latest Trial Data on GA Depot in Treating RRMS and PPMS Mapi PharmaĀ will presentĀ recent advances in its potential multiple sclerosis (MS) therapies, including GA Depot, at the 35thĀ Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) opening this week. ECTRIMS runs from Wednesday through Friday, Sept. 11ā13, in Stockholm. Among the work disclosed will be…
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 8, 2019 News by Jose Marques Lopes, PhD Medicare Rules, Higher Cost-sharing Load Increase Out-of-pocket Spending for MS Therapies, Study Reports Restrictive access policies by Medicare and a rising cost-sharing burden lead to an increased price of disease-modifying therapies for multiple sclerosis patients, according to new research. The findings also revealed that Medicare beneficiaries without a low-income subsidy may spend on average $6,894 for their MS treatments in 2019, with generic versions of Copaxone representing the highest burden. Approximately 25-30% of patients with MS are covered by Medicare through disability. In 2013, MS Medicare beneficiaries with MS and without low-income subsidies averaged $4,389 a year in out-of-pocket expenses, second only to hepatitis. Despite a greater number and diversity of DMTs for MS treatment, their price has increased substantially over the past two decades. In fact, expenses related to DMTs for MS are among the highest by class in the Medicare market. āItās a dysfunctional market that lacks the typical incentives for most other consumer prices,ā Daniel Hartung, the studyās lead author, said in anĀ Oregon Health & Science University (OHSU) press release written by Erik Robinson. āAside from the public optics, there are few incentives for companies not to raise prices. Most intermediaries in the drug distribution channel, including drug companies, benefit from higher prices,ā Hartung said. These high prices may lead to reduced access, as insurance companies can restrict coverage or manage use through prior authorization or step-therapy policies, and high deductibles or cost-sharing components in health plans that increase the financial burden for patients. Now, a team at OHSU and theĀ Oregon State University College of Pharmacy used prescription drug plan formulary files to analyze changes in coverage policies from 2007 to 2016, and to estimate out-of-pocket spending for DMTs for MS within Medicare Part D program, through which outpatient prescriptions are financed. Eleven DMTs available during the study period were analyzed. Tysabri and Lemtrada were not part of the analysis because they are delivered via intravenous infusion in the clinic setting, and are typically covered through Medicare Part B. Results revealed that the price for Betaseron , Copaxone 20 mg , Rebif, and Avonex ā the four therapies available in 2007 ā quadrupled over the 10-year study period. Except for Copaxone 40 mg and its 20 mg generic formulation (Glatopa, by Sandoz), prices for the other DMTs introduced after 2007 increased by 9ā13% per year. These include Novartisā Extavia (interferon beta-1b) and Gilenya (fingolimod), Biogenās Plegridy (peginterferon beta-1a) and Tecfidera (dimethyl fumarate), and Sanofi Genzymeās Aubagio (teriflunomide). In 2007, 99-100% of plans covered the four available medications, with the exceptions being Rebif (88%). These percentages fell to 54-89% in 2016. Coverage of the other DMTs varied between 21% (Extavia) to 92% for Copaxone 40 mg. In turn, coverage for the three oral options ā Gilenya, Aubagio and Tecfidera ā generally increased or was maintained over time, ranging from 46% for Aubagio to 83% for Gilenya. The use of prior authorization increased from 61-66% in 2007, to 84-90% in 2016. Also, the share of plans with at least one DMT available without limitations declined from 39% to 17%. The average projected out-of-pocket spending for 2019 across DMTs was $6,894. The highest projected out-of-pocket expenses ($8,219) are associated with generic glatiramer acetate, both Glatopa and Mylanās 20 mg/mL and 40 mg/mL generic formulations, approved by the U.S. Food and Drug Administration in 2017. This is more than with any of Copaxoneās formulations. According to the team, this is the result of a higher coinsurance payment (37% vs. 25%) expected for generic medications compared to brand-name options, as well as the fact that manufacturers of generics do not provide discounts toward a beneficiaryās total out-of-pocket spending, unlike what is mandated by the Affordable Care Act for brand-name therapies. āThis is a pernicious effect of the release of a generic and an unfortunate effect of Medicare rules,ā Dennis Bourdette, MD, one of the studyās co-authors, said. A proposal by U.S. President Donald Trump's administration addresses this by eliminating manufacturer discounts from the calculation to determine a patientās total out-of-pocket spending. Such strategy would reduce the disparity between brand-name and generic therapies, the researchers said. āIn this study we found that Medicare beneficiaries with MS who require a [DMT] face considerable policy-related access restrictions and high out-of-pocket spending,ā the researchers wrote. āThere is an urgent need for policies that slow the growth of drug prices, improve access, and shield patients from excessively high out-of-pocket spending,ā they concluded.
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…
August 6, 2018 News by Ana Pena PhD Glatect, Alternative to Copaxone, Added to Public Health Plans of 5 Canadian Provinces Pendopharmās Glatect (glatiramer acetate injection), a lower cost alternative toĀ Tevaās Copaxone, has been added to the public health plans of five Canadian provinces for patients with…
July 27, 2018 News by Alice MelĆ£o, MSc Oral DMTs Still Common 1st Therapy for New MS Patients but Ocrevus Having Impact, Market Report Says Oral disease-modifying therapies (DMTs) are the most common first choice of treatment for people newly diagnosed with multiple sclerosis (MS) in the United States, an analysis reports. Antibody-based DMTs like Ocrevus, however, are emerging competitors. Spherix Global Insights, a market research and analysis company, states that 1 in every…
April 12, 2018 News by Stacy Grieve, PhD First Generation Disease-modifying Therapies Pose Low Infection Risk in MS, Study Finds A large group study showed that first-generation disease-modifying therapies (DMTs) do not increase the infection risk in multiple sclerosis (MS) patients. Many of the DMTs used to reduce the risk of relapse in MS target the immune system and cause a suppression of the inflammatory response. Although helpful in…
April 11, 2018 News by Alice MelĆ£o, MSc Mapi Pharma, Mylan Partner to Develop Once-monthly Glatiramer Formulation Mylan andĀ Mapi Pharma will jointly develop and commercialize Glatiramer Acetate (GA) Depot, an investigative, long-lasting formulation of the commonly used multiple sclerosis (MS) therapyĀ CopaxoneĀ (marketed by Teva Phatmaceutical). Under the terms of the partnership, Mylan will acquire global marketing rights for the therapy. The companies are in…
February 27, 2018 Columns by Ed Tobias What’s Hot and What’s Not Among MS Therapies? The newest kids on the MS block, disease-modifying therapies (DMT) such as Genentech’s Ocrevus (ocrelizumab) and Sanofi Genzyme’s Lemtrada (alemtuzumab), are attracting a lot of interest these days. But, some DMTs that have been around for more than two decades are still being prescribed by a lot of neurologists.
February 15, 2018 News by Patricia Silva, PhD FDA Approves Dose of MS Therapy Glatopa That Is Twice as Large as Current One The U.S. Food and Drug Administration has approved a new dose ofĀ Sandozās multiple sclerosis therapyĀ Glatopa (glatiramer acetate injection)Ā that is twice as large as the currently authorized one. Regulators’ approval of theĀ 40 mg/mL applies to people with relapsing forms of MS. A mg/mL designation refers to the concentration of…
February 1, 2018 News by Jose Marques Lopes, PhD Mapi Pharma Doses First PPMS Patient in Phase 2 Trial Evaluating GA Depot The Phase 2a trial of GA Depot (glatiramer acetate) for the treatment of primary progressive multiple sclerosis (PPMS) has dosed the first patient,Ā Mapi PharmaĀ recently announced. In the U.S., Copaxone (glatiramer acetate injection, marketed by Teva Pharmaceutical) is the standard therapy for relapsing-remitting multiple sclerosis (RRMS), which is…
January 26, 2018 News by Jose Marques Lopes, PhD Brabio, 1st Generic Version of Copaxone for Relapsing MS, Launched in UK Brabio (glatiramer acetate injection), the first generic alternative to CopaxoneĀ for relapsing multiple sclerosis (MS) patients, was recently launched in the U.K. at an equivalent higher dose, its maker,Ā Mylan, announced. Similar to Copaxone Ā ā developed by TevaĀ āĀ Brabio is now available at a 40 mg/ml dose. Both medications are…