Glatopa, a generic form of Copaxone, is a glatiramer acetate injection designed to treat patients with relapsing and remitting forms of multiple sclerosis (RRMS). Approved for that indication by the U.S. Food and Drug Administration (FDA), it is manufactured and marketed jointly by Momenta and Sandoz (a Novartis company). The formulation aims to reduce the intensity of flares, or exacerbations, in RRMS patients and to increase the time interval between relapses, so as to reduce disease progression.
How Glatopa Works
Chemically an equivalent of Copaxone 20mg/ml (an FDA-approved drug for RRMS patients, manufactured by Teva Pharmaceuticals), Glatopa works by modulating harmful immune responses that damage myelinated neurons in the central nervous system (CNS). Though the therapy’s exact mechanism of action is unclear, it is believed that the drug upregulates the population of regulatory T-cells, reduces T-cells responsible for damage to myelin sheaths, induces secretion and upregulation of suppressor T-cells in the peripheral bloodstream, and/or induces increased expression of neurotrophic factors that help in the growth and maintenance of mature neurons. Another mechanism of action suggested for glatiramer acetate is interference in antigen presentation by autoimmune cells in the host. However, this action is debatable.
Clinical Trials for Copaxone
Preclinical studies in Copaxone involved mice with MS, called an experimental autoimmune encephalomyelitis (EAE) model. Promising results in terms of reduced demyelination and axonal loss in treated mice led to development of clinical trials involving humans, testing the drug’s safety, efficacy, and toxicity in healthy participants and RRMS patients. These studies, demonstrating a reduction in disease flare and flare rates, as well as safety and efficacy, led to FDA approval. Glatopa, as a generic version of a proprietary drug, needed to prove only bioequivalency to Copaxone, which it did. On April 16, 2015, it became the first generic version of Copaxone to be approved by the FDA.
The dosage for the drug is recommended at 20 milligrams (mg) injected under the skin once a day. Common side effects can include chest pain, flushing, heart palpitations, anxiety, trouble breathing, a tight feeling in the throat, and these effects should disappear within minutes of an injection. If depressed or indented skin, blue-green to black skin discoloration, or pain, redness, or sloughing (peeling) of the skin is noticed at the site of injection, a doctor should be informed. This may be due to localized lipoatrophy or, in rare cases, skin necrosis at the injection site. Pregnant or breastfeeding women should also consult a specialist before using the medication, although the drug has not shown any harmful effects on infants or newborns.
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