July 27, 2022 News by Margarida Maia, PhD Natalizumab, Biosimilar of Tysabri for Relapsing MS, Under FDA Review The U.S. Food and Drug Administration (FDA) has agreed to review an application requesting thatĀ Polpharma Biologics‘ natalizumab, a biosimilar of Tysabri, be approved to treat relapsing forms ofĀ multiple sclerosis (MS). Its intended U.S. use is for the same indications as the approved name-brand medicine, coveringĀ clinically isolated…
July 19, 2022 News by Marisa Wexler, MS Natalizumab, Tysabri Biosimilar, Up for Approval in Europe The European Medicines Agency (EMA) has agreed to review a request to approveĀ Polpharma Biologics‘ biosimilar natalizumab for the treatment of multiple sclerosis (MS). This marks the first time the regulatory agency accepted a marketing authorization application for a biosimilar of Tysabri, anĀ approved MS treatment. “The acceptance…
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…
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…
May 12, 2020 News by Marta Figueiredo, PhD COVID-19 May Not Be Severe in MS Patients, Early Data from Italy Suggest People with multiple sclerosis (MS) may not be at higher risk of developing a severe COVID-19 infection, according to preliminary data from patients in Italy. āAt the moment, these results seem to be quite reassuring for most people with MS,ā Marco Salvetti, MD, PhD, professor at Sapienza…
September 5, 2019 News by Joana Carvalho, PhD Sandoz Enters Agreement with Polpharma Biologics to Develop and Commercialize Tysabri Biosimilar Sandoz, a division of Novartis dedicated to the development of biosimilars, has entered an agreement with Polpharma Biologics, a biopharmaceutical company also dedicated to the manufacture of biosimilars, to develop and market a biosimilar to Biogen‘sĀ Tysabri (natalizumab). Tysabri is a disease-modifying therapy (DMT) that wasĀ …
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."
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…
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…
September 18, 2017 News by Patricia Silva, PhD Synthon Wins EU Patent Case Against Teva, Paving Way for Generic Copaxone for MS Patients AĀ European Patent OfficeĀ decision has opened the door toĀ SynthonĀ providing cheaper generic versions of Teva Pharmaceuticalās Copaxone to people withĀ relapsing multiple sclerosis. What looks like the final hurdle to the generics was cleared when the patent office’sĀ Technical Board of Appeal revoked the last of the patents that Teva…
April 17, 2015 News by Patricia Silva, PhD First Generic Version of Copaxone Approved by FDA to Treat Multiple Sclerosis The U.S. Food and Drug Administration (FDA) has announced the approval of the first generic version ofĀ CopaxoneĀ (glatiramer acetate injection) for the treatment ofĀ relapsing forms of multiple sclerosis (MS). The administration has grantedĀ Sandoz marketing authorization forĀ glatiramer acetate in 20 mg/1 ml…