Glatiramer acetate

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.

The U.S. Food and Drug Administration has approved a new dose of Sandoz’s multiple sclerosis therapy Glatopa (glatiramer acetate injection) that is twice as large as the currently authorized one. Regulators’ approval of the 40 mg/mL applies to people with relapsing forms of MS. A mg/mL designation refers to the concentration of…

The Phase 2a trial of GA Depot (glatiramer acetate) for the treatment of primary progressive multiple sclerosis (PPMS) has dosed the first patient, Mapi Pharma 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…

Brabio (glatiramer acetate injection), the first generic alternative to Copaxone for relapsing multiple sclerosis (MS) patients, was recently launched in the U.K. at an equivalent higher dose, its maker, Mylan, announced. Similar to Copaxone  — developed by Teva — Brabio is now available at a 40 mg/ml dose. Both medications are…

U.S. neurologists are increasingly prescribing Genentech’s Ocrevus (ocrelizumab) to their multiple sclerosis patients, Spherix Global Insights reports. Another good sign for Genentech is that, in just three months, neurologists have increased by 50 percent their estimate of the numbers of relapsing-remitting MS patients who could benefit from Ocrevus.

Synthon’s prefilled syringe with 40 mg/ml of glatiramer acetate — the generic version of Teva Pharmaceutical’s Copaxone 40 mg — has received regulatory clearance in all 28 member states of the European Union (EU) plus Iceland, Liechtenstein and Norway to treat relapsing-remitting multiple sclerosis (RRMS). The low-dose…

The U.S. Food and Drug Administration has approved both lower and higher doses of Mylan’s generic versions of Copaxone (glatiramer acetate) for relapsing multiple sclerosis. It is the first time the agency has authorized a higher-dose generic. Generic versions of the lower dose of 20 mg/mL — intended for…

A European Patent Office decision has opened the door to Synthon providing cheaper generic versions of Teva Pharmaceutical’s Copaxone to people with relapsing multiple sclerosis. What looks like the final hurdle to the generics was cleared when the patent office’s Technical Board of Appeal revoked the last of the patents that Teva…

First-line treatment with Copaxone (glatiramer acetate) benefits relapsing-remitting multiple sclerosis (RRMS) patients by boosting the number of anti-inflammatory immune cells and restoring the balance of regulatory immune cells, an Italian study shows. The study, “Biological activity of glatiramer acetate on Treg and anti-inflammatory monocytes persists for more than 10…

Multiple sclerosis patients taking Tecfidera, or dimethyl fumarate, were more productive at work than those on Copaxone or beta-interferon therapies, according to a study. Tecfidera also increased patients’ quality of life, researchers said. The study covered patients with relapsing-remitting multiple sclerosis, or RRMS. The four beta-interferon treatments were Avonex, Betaseron, Rebif,…

Babies of women with relapsing multiple sclerosis (RMS) who receive daily injections of Copaxone (glatiramer acetate) while pregnant carry the same risk of developing birth defects as babies as a whole, according to a study by the therapy’s developer, Teva Pharmaceutical Industries. The findings can help doctors counsel and treat…

Teva Pharmaceutical Industries will discuss two of its multiple sclerosis therapies, one that reduces relapses and one that appears to protect nerve structure, at a premier neurology conference in Boston this month. It will also give presentations at the 2017 Annual Meeting of the American Academy of Neurology on therapies…

An extension trial assessing generic glatiramer acetate (GTR) treatment in multiple sclerosis (MS) patients found that the formulation is as safe and effective as Copaxone (branded glatiramer acetate), and that switching to GTR is well-tolerated. The findings were in the study, “Switching from branded to generic glatiramer acetate:…

Alvogen recently announced the launch of Remurel (glatiramer acetate) in Central and Eastern Europe, making it the first generic equivalent of Copaxone  to be clinically validated for the treatment of relapsing forms of multiple sclerosis (RRMS) in Europe. European health authorities determined that Remurel 20 mg was the therapeutic equivalent…

Multiple sclerosis patients are at risk of developing lymphopenia, or abnormally low levels of immune defense white blood cells, called lymphocytes, according to a study that investigated lymphocyte counts in people with relapsing MS both before and after the start of treatment. The study, “Lymphopenia in treatment-naive relapsing multiple…

Health Canada has approved Teva Canada Innovation‘s three-time weekly 40 mg/mL injection of Copaxone (glatiramer acetate) that allows less frequent dosing for patients with relapsing-remitting multiple sclerosis (RRMS). The approval was grounded primarily on data resulting from the Phase 3 Glatiramer Acetate Low-Frequency Administration (GALA) study, the largest Copaxone clinical…

The Russian Ministry of Health recently granted Marketing Authorization (ЛП-003567) to R-Pharm JSC for the development of  “Glatirat” (Glatiramer acetate), a drug intended for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS) and clinically isolated syndrome. According to a press release, the registration of “Glatirat” was based…

Stable multiple sclerosis (MS) patients do not appear to be at any increased risk of disease reactivation while switching to oral therapy following treatment with injectable interferon-β/glatiramer acetate (IFNβ/GA), a study reports. Recently published in the European Journal of Neurology, the Australian study was titled “Risk of early…

Results from a small pilot study indicated that high-dose vitamin D supplementation is safe and tolerable in patients with multiple sclerosis (MS), and that it can reduce the presence of autoimmunity-causing immune T cells. Patients are now being recruited for a larger clinical trial. The study, entitled “Safety and immunologic…

Takeda Pharmaceutical, a pharmaceutical company based in Osaka, Japan, recently announced that a widely approved drug treatment for the prevention of relapses in multiple sclerosis (MS) is now available in Japan as well. Copaxone, (glatiramer acetate; 20 mg daily subcutaneous injection), developed by Teva Pharmaceuticals, is an immunomodulatory drug designed to act as…

Synthetic Biologics, which specializes in the development of therapies for pathogen-specific diseases, recently announced the publication of new and positive data on results from a Phase 2 clinical trial evaluating the company’s product Trimesta™ as a treatment for relapsing-remitting multiple sclerosis (RRMS) in women. Professor Rhonda Voskuhl, director of the Multiple Sclerosis Program…

In a recent study entitled “Equivalent Gene Expression Profiles between Glatopa™ and Copaxone®,” authors determined potential differences in treatment responses by investigating the gene expression profile of two approved treatments for relapsing forms of multiple sclerosis – Copaxone and Glatopa. Both of these MS therapies are glatiramer…

A Satellite Symposia entitled “Discovering a new world in MS” presented by Teva Neuroscience was held yesterday, October 8 at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) currently taking place in Barcelona, Spain, October 7 – 10, 2015. Dr. Omar Khan from the…

The U.S. Food and Drug Administration (FDA) has announced the approval of the first generic version of Copaxone (glatiramer acetate injection) for the treatment of relapsing forms of multiple sclerosis (MS). The administration has granted Sandoz marketing authorization for glatiramer acetate in 20 mg/1 ml…

Takeda Pharmaceutical Company Limited (Takeda) announced late last month its New Drug Application (NDA) to Japan’s Ministry of Health, Labour and Welfare for the multiple sclerosis relapse prevention drug glatiramer acetate (active ingredient) — which is sold in some markets under the trade name Copaxone. Developed by Israel’s Teva Pharmaceutical Industries…

Mapi Pharma Ltd., a development stage pharmaceutical company specializing in the development of high-barrier to entry and high-added value generic drugs, announced it has treated the first patient in the Phase IIa study of GA Depot for relapsing-remitting multiple sclerosis (RRMS). Lead investigator Professor Ariel Miller, M.D., Ph.D., Head of the Multiple Sclerosis & Brain…

Israel-based biopharmaceutical company Teva Pharmaceutical Industries Ltd. announced last week that its thrice-weekly COPAXONE® (glatiramer acetate) 40mg/ml treatment for relapsing-remitting multiple sclerosis (RRMS) has received positive results in a decentralized procedure. The favorable outcome proceeds a Positive Assessment Report from the United Kingdom, the Reference Member…

Teva Pharmaceutical Industries Ltd., the company behind multiple sclerosis drug COPAXONE® (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. Teva’s petition has been turned down several times,…

A new study, entitled “The Effect of Glatiramer Acetate Therapy on Functional Properties of B Cells From Patients With Relapsing-Remitting Multiple Sclerosis” published online in JAMA Neurology, reports the effect of Glatiramer acetate therapy on B cells in relapsing-remitting multiple sclerosis (MS) patients. This first-of-its-kind study could…

The U.S. Food and Drug Administration (FDA) accepted the abbreviated new drug application (ANDA) for filing of a Glatiramer Acetate Injection for the treatment of patients with relapsing forms of multiple sclerosis (MS).