Glatopa, a generic form of Copaxone, is a glatiramer acetate injection treatment for people with relapsing forms of multiple sclerosis: clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS) and active secondary progressive MS (SPMS).
First approved by the U.S. Food and Drug Administration (FDA) in 2015, it is marketed by Sandoz (a Novartis company). Glatopa, like Copaxone, is believed to work by decreasing the activity of immune cells that cause nervous system damage, lengthening the time interval between relapses so as to slow disease progression.
How Glatopa Works
Chemically an equivalent of Copaxone at 20mg/ml and 40 mg/ml (an FDA-approved relapsing MS injection treatment, manufactured by Teva Pharmaceutical), Glatopa works by modulating harmful immune responses that damage myelinated neurons in the central nervous system (CNS).
Glatiramer acetate is a small synthetic protein, made to mimic a fragment of myelin. It consists of four amino acids, the building blocks of proteins, that are found in myelin.
The exact mechanism of how Glatopa, like Copaxone, works to reduce the frequency of relapses in RRMS is not known, but it is thought that the medicine modifies the immune response against myelin. For example, these treatments may act to increase the immune system’s tolerance to myelin through repeated exposure, in a similar way to a vaccine.
Another mechanism could be that it alters which immune cells are active; it may be able to induce a type of immune cells called suppressor T-cells that secrete anti-inflammatory proteins and prevent damage. Copaxone may also act to prevent the activation of T-cells that target and attack myelin.
While Glatopa can reduce the rate of relapses and slow the progression of MS, it cannot reverse or cure the disease.
Clinical Trials for Copaxone
The key clinical trial that led to Copaxone’s approval for marketing was a study called the Copolymer 1 Multiple Sclerosis Study, carried out in the 1990s. The randomized, double-blind, placebo-controlled Phase 3 trial enrolled 251 patients with RRMS who received either Copaxone or a placebo daily for two years.
The initial results, published in the journal Neurology, demonstrated that patients receiving Copaxone had a 29 percent reduction in their relapse rate compared to those who received placebo. Patients also were assessed in terms of their change on the expanded disability status scale, after two years of treatment compared to the start of the trial. On average, patients taking Copaxone had an improved score after two years, while the score of patients in the placebo group had worsened. The treatment was well-tolerated, with the most common side effect being a reaction at the injection site.
More recently, the effectiveness of Copaxone given at a higher dose, 40 mg three times weekly instead of 20 mg daily, was assessed in a randomized placebo-controlled Phase 3 trial (NCT01067521) called GALA. A total of 1,404 participants with RRMS were recruited worldwide to receive Copaxone or a placebo for one year. This also was followed by an open label extension study.
The results, published in the Annals of Neurology, confirmed that Copaxone reduced the number of relapses compared to placebo, by about 34 percent. The patients also were assessed by magnetic resonance imaging (MRI) to check for lesions, or areas of damage, in the brain. Copaxone was associated with a significant reduction in the number of lesions compared to the placebo.
On April 16, 2015, Glatopa became the first generic version of Copaxone to be approved by the FDA.
The recommended dosage is 20 milligrams (mg) injected under the skin once a day, or 40 mg injected three times a week.
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 consult a specialist before using the medication.
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