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…
December 29, 2021 News by Steve Bryson, PhD Higher, Fewer Copaxone Doses Lowered Relapse Rates Over 7 YearsĀ A higher dose of Copaxone (glatiramer acetate) given three times weekly over seven years led to sustainably lower relapse rates and slowed disability progression inĀ multiple sclerosis (MS) patients, according to a long-term analysis of the GALA study. The higher dose āĀ 40 mg/mL ā was generally well-tolerated with no…
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…
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…
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…
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…
November 4, 2019 News by Iqra Mumal, MSc Teva-Fingolimod, Generic and Bioequivalent Version of Gilenya, Available in Canada Teva Canada announced that Teva-Fingolimod 0.5 mg capsules, a bioequivalent generic version ofĀ Novartisā Gilenya (fingolimod), are now available in Canada and approved by the country’s national health system calledĀ Health Canada. GenericĀ medicines are chemically identical to the original branded therapy, but carry a significantly lower cost. Canadian…
October 11, 2019 News by Ana Pena PhD Mavenclad, Ocrevus Use Rising in EU as Injectables and Tysabri Decline, Spherix Reports Prescriptions of two multiple sclerosisĀ (MS) treatments ā Ā Merck KGaA‘s Mavenclad (cladribine) and Roche‘s Ocrevus (ocrelizumab) ā have been rising in Europe over the past six months, bolstered by greater market access and compassionate use programs, according to a survey of 250 EU neurologists run…
September 16, 2019 News by Jose Marques Lopes, PhD #ECTRIMS2019 – Newer DMTs More Effective Than Older Injectables in Pediatric MS, Study Says Using newer disease-modifying therapies (DMTs) as an initial treatment for children and adolescents with multiple sclerosis (MS) or clinically isolated syndrome (CIS) is associated with fewer relapses and brain lesions compared to the use of older and injectable DMTs, according to a real-world study in the U.S.
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…
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 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 7, 2015 News by Patricia Silva, PhD Teva Pharmaceuticals to Present New Data on Multiple Sclerosis Drugs Copaxone and Laquinimod at ECTRIMS 2015 The world’sĀ largest generic medicines manufacturer,Ā Teva Pharmaceutical, is at theĀ 31st European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Congress currently ongoing in Barcelona, from October 7-10, 2015. Teva will be presenting the latest findings on its relapsing multiple sclerosis (MS) therapy COPAXONEĀ®Ā (glatiramer acetate injection), and product candidate for…
September 4, 2015 News by Marta Silva Mylan Confirms Continued Patent Proceedings Concerning MS Therapy Copaxone According toĀ a press release from Mylan N.V., the U.S. Patent and Trademark Office (PTO) has issuedĀ an inter partes review (IPR) proceeding on all claims against a third Copaxone patent for the 40 mg/mL (U.S. Patent No. 8,969,302) formulationĀ by Yeda Research & Development Co., Ltd.
August 4, 2015 News by Patricia Silva, PhD Pfizer Acquires Exclusive Commercialization Rights to Generic Copaxone for Relapsing Remitting Multiple Sclerosis Netherlands-based international pharmaceutical company Synthon, best known for developing complex generic therapeutics, has officially entered into an agreement with pharmaceutical giant Pfizer, Inc., effectively transferring the exclusive rights in the US to glatiramer acetate to Pfizer. Glatiramer acetate is an experimental generic formulation of Copaxone, which is indicated as a…
June 3, 2015 News by Patricia Silva, PhD Jack Osbourne and Teva Launch New Educational Multiple Sclerosis Website Reality TV star Jack Osbourne has partnered with Teva Pharmaceutical Industries Ltd. to launch aĀ new website as part ofĀ aĀ three-year campaign called You Don’t Know Jack About MS. The site can be viewed here: www.youdontknowjackaboutms.com. The campaign is meant to raise awareness about…
January 26, 2015 News by Patricia Silva, PhD US Supreme Court Rules on Teva Pharma’s Copaxone Patent Case Teva Pharmaceutical Industries Ltd. recently made a major announcement on the U.S. Supreme Court‘s ruling on the matter of “Teva Pharmaceuticals USA, Inc. et al. Petitioners v. Sandoz Inc. et al. that reversed the Federal Circuit Courtās judgment of invalidity…
December 9, 2014 News by Patricia Silva, PhD 3 Times a Week Dose Copaxone for Relapsing MS Receives Positive Outcome in Europe Israel-based biopharmaceutical companyĀ Teva Pharmaceutical Industries Ltd. announced last week that its thrice-weekly COPAXONEĀ® (glatiramer acetate) 40mg/ml treatment for relapsing-remitting multiple sclerosis (RRMS) has received positive results in a decentralized procedure. The favorable outcome proceeds aĀ Positive Assessment Report from the United Kingdom, the Reference Member…
December 1, 2014 News by Patricia Silva, PhD FDA Delays Ruling on Teva Petition Against Generic Copaxone for MS Teva Pharmaceutical Industries Ltd., the company behind multiple sclerosis drugĀ COPAXONEĀ® (glatiramer acetate injection), has been pursuing the US Food and Drug Administration‘s decision against approving a generic version of the drug, by Mylan, Inc.Ā Teva’s petition has been turned down several times,…
November 17, 2014 News by Patricia Silva, PhD Teva Pursues Regulatory Approval in Japan for MS Drug Copaxone Teva Pharmaceutical Industries Ltd., the company that developed the injectable multiple sclerosis treatment Copaxone (Glatiramer acetate), Ā has announced their pursuit of regulatory approval in Japan. This development comes a year after signing an agreement with Takeda Pharmaceutical Co. Ltd. According to a…
November 13, 2014 News by Patricia Silva, PhD Multiple Sclerosis Association of America Launches New Patient Support Website One of the country’s leading non-profit multiple sclerosis organizations, the Multiple Sclerosis Association of America (MSAA), has just launched a new patient support website called, My MS Journey. It is a comprehensive online resource designed to answer the specific and varied needs of MS patients, whether they have…
November 5, 2014 News by Patricia Silva, PhD Teva and Active Biotech Expand Investigational MS Treatment Program Drug manufacturersĀ Teva Pharmaceutical Industries Ltd.Ā and Active Biotech announced that they expanding the ongoing clinical research program for the study ofĀ laquinimod, a potential treatment for primary progressive multiple sclerosis (PPMS), as the companies are now initiating theĀ ARPEGGIO trial. In addition, Teva has also announced…
October 16, 2014 News by Patricia Silva, PhD U.S. Supreme Court Gives Teva Mixed Reception on Copaxone Patent Case The U.S. Supreme Court deliberated on a request from Teva Pharmaceutical Industries Ltd. to preserve the patent of its multiple sclerosis drug Copaxone from generic competitors until September 2015. Recent reports indicate that the court gave the company a mixed opinion. The hearing occurred this…
September 2, 2014 News by Patricia Silva, PhD Mylan’s Generic Copaxone Injection ANDA Approved for Filling by the FDA The U.S. Food and Drug Administration (FDA) acceptedĀ theĀ abbreviated new drug application (ANDA)Ā forĀ filingĀ of aĀ Glatiramer Acetate InjectionĀ for the treatment of patients with relapsing forms of multiple sclerosis (MS).
May 26, 2014 by Patricia Silva, PhD Multiple Sclerosis Drug NerventraĀ® (Laquinimod) Disapproved in EU; Drug Developers Will Continue Research Two pharmaceutical companies,Ā Teva Pharmaceutical Industries Ltd. (TEVA) and Active Biotech, have just confirmed reports that theĀ Committee for Medicinal Products for Human Use (CHMP) is not recommendingĀ NERVENTRA (laquinimod) for use in treatingĀ relapsing-remitting multiple sclerosis (RRMS) within the European Union (EU), according to a recent press release. Despite CHMP’s disapproval of TEVA…
April 21, 2014 by Charles Moore Supreme Court Denies Injunction Request To Block Release Of Generic MS Drug, But Patent Fight Not Over Yet Petah Tikvah Israel-basedĀ Teva Pharmaceutical Industries Ltd.Ā has suffered a setback in its fight to forestall release of generic competitors for its proprietary Copaxone Multiple Sclerosis drug. However, the company is expressing optimism that potential for recovery of Patent Infringement Damages may dissuade aspirant generic competitors from proceeding until a…