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Trade names | Copaxone, Glatopa |
AHFS/Drugs.com | Monograph |
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Subcutaneous injection |
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Formula | C25H45N5O13 |
Molar mass | 623.65 g/mol |
(what is this?) |
Glatiramer acetate (also known as Copolymer 1, Cop-1, or Copaxone - as marketed by Teva Pharmaceuticals) is an immunomodulator drug currently used to treat multiple sclerosis. It is a random polymer of four amino acids found in myelin basic protein, namely glutamic acid, lysine, alanine, and tyrosine, and may work as a decoy for the immune system. Glatiramer acetate is approved by the Food and Drug Administration (FDA) for reducing the frequency of relapses, but not for reducing the progression of disability. Observational studies, but not randomized controlled trials, suggest that it may reduce progression of disability.
While a conclusive diagnosis of multiple sclerosis requires a history of two or more episodes of symptoms and signs, glatiramer acetate is approved to treat a first episode anticipating a diagnosis. It is also used to treat relapsing-remitting multiple sclerosis. It is administered by subcutaneous injection.
A 2004 Cochrane review concluded that glatiramer acetate "did not show any beneficial effect on the main outcome measures in MS, i.e. disease progression, and it does not substantially affect the risk of clinical relapses."
A trial of 251 patients, after two years failed to show any advantage in halting disability progression. As a result, it is approved by the FDA for reducing the frequency of relapses, but not for reducing the progression of disability.
A 15-year followup of the original trial compared patients who continued with glatiramer to patients who dropped out of the trial. Patients with glatiramer had reduced relapse rates, and decreased disability progression and transition to secondary progressive MS, compared to patients who did not continue glatiramer. However, the two groups were not necessarily comparable, as it was no longer a randomized trial. There were no long-term safety issues.