The U.S. Food and Drug Administration (FDA) has approved Scinopharm Taiwan’s glatiramer acetate injection, a generic of Copaxone, to treat multiple sclerosis (MS). Scinopharm is the first pharmaceutical company in Taiwan to win U.S. approval for glatiramer acetate, marking a significant milestone…
Copaxone
For children and adolescents with multiple sclerosis (MS), receiving treatment with Copaxone (glatiramer acetate) or its generic formulations may reduce relapses by nearly threefold compared with Avonex (interferon beta-1a), according to data from a clinical trial. However, nearly half of patients on Copaxone and one-third of those…
Researchers have identified a genetic biomarker that predicts whether people with relapsing forms of multiple sclerosis (MS) will respond to glatiramer acetate (sold as Copaxone, among others) therapy. A study based on an analysis of more than 3,000 MS patients showed that those who carry a form of…
The U.S. Food and Drug Administration (FDA) has approved a new generic form of glatiramer acetate injection, a treatment for relapsing forms of multiple sclerosis (MS) that was originally approved under the brand name Copaxone. The generic was developed by Zydus Lifesciences in collaboration with Chemi S.p.A.,…
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 U.S. Food and Drug Administration (FDA) has added a new boxed warning to the prescribing information for glatiramer acetate, an approved injection therapy for relapsing forms of multiple sclerosis (MS) that’s sold under the brand name Copaxone and is also available as generic products. A boxed warning…
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…
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…
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,…
For the first time, multiple sclerosis (MS) therapies have been added to the World Health Organization (WHO)’s Model Lists of Essential Medicines (EML), which names those regarded as meeting the most important needs of healthcare systems worldwide. Glatiramer acetate (sold as Copaxone with generics available), Mavenclad (cladribine)…
Welcome to “MS News Notes,” where I comment on multiple sclerosis (MS) news stories that caught my eye last week. Here’s a look at what’s been happening: Is cost a factor when deciding DMT use? Cost may be the elephant in the room when people with MS are…
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…
Taking the pregnancy hormone estriol in combination with Copaxone (glatiramer acetate) significantly reduced the blood levels of neurofilament light chain (NfL) — a marker of nerve damage — in women with relapsing-remitting multiple sclerosis (RRMS), clinical trial data show. These lower NfL levels were significantly associated with a…
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…
Reports of psoriasis — an autoimmune skin disease that shares some biological processes with multiple sclerosis (MS) — are disproportionally high among MS patients on therapies that deplete B-cells, according to a U.S. study based on patient adverse event data. Conversely, patients on Tysabri (natalizumab), glatiramer acetate (sold…
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 higher dose of Copaxone (glatiramer acetate) given three times weekly over seven years led to sustainably lower relapse rates and slowed disability progression in multiple sclerosis (MS) patients, according to a long-term analysis of the GALA study. The higher dose — 40 mg/mL — was generally well-tolerated with no…
Treatment with Copaxone (glatiramer acetate), an approved therapy for relapsing forms of multiple sclerosis (MS), while breastfeeding does not appear to be harmful to infants in their first years, a study has found. Investigators observed no differences between infants whose mothers were taking Copaxone and those whose mothers weren’t…
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…
The U.S. Justice Department has the manufacturer of Copaxone (glatiramer acetate injection) in its crosshairs, and the outcome could have a much greater reach. It appears the case could directly affect the copay help many of us receive for our medications and the patient services some drug companies provide.
NeuroScientific Biopharmaceuticals’ Lead Candidate, EmtinB, Shows Promise in Preclinical Model of MS
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…
MS News that Caught My Eye Last Week: Vascular Disease, Glatopa vs. Copaxone, Exercise Tips, MS App
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…
Like most of you, I take medication for my multiple sclerosis. Copaxone is my medication of choice, though I have recently switched to the generic version, glatiramer acetate. I’ve taken shots every day for years, so I was thrilled when the dosage dropped to three days a week.
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…
One of the toughest decisions facing someone with MS is whether to begin treatment with a disease-modifying therapy (DMT). Equally tough, I think, is deciding which DMT road to travel — because there are three roads that can be followed. One path starts you on a simple, first-level medication.
Four disease-modifying therapies (DMTs) for multiple sclerosis — Avonex, Rebif, Betaferon, and Copaxone — are cost-effective and reduce disease progression in MS patients, especially those with relapsing-remitting disease, according to 10-year, real-world results from U.K.’s MS Risk Sharing Scheme (RSS). But the long-term benefits observed wane over…
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