Copaxone (Glatiramer Acetate Injection)

Copaxone (glatiramer acetate injection) is a disease-modifying treatment widely approved for adults with relapsing forms of multiple sclerosis (MS), which includes clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), and active secondary progressive multiple sclerosis (SPMS).

The name-brand medication is marketed by Teva Pharmaceuticals. Generic versions of Copaxone are also widely available, including Glatopa, by Sandoz (a Novartis company), and Glatiramer Acetate Injection, by Mylan Pharmaceuticals, now part of Viatris.

How does Copaxone work?

MS is caused by the body’s immune system erroneously attacking healthy cells in the nervous system. In particular, the autoimmune attack in MS targets myelin — a fatty substance that wraps around nerve fibers like a sheath, and is critical for sending electrical signals.

The active agent in Copaxone, glatiramer acetate, is basically a synthetic protein that is designed to mimic a piece of myelin. It consists of four amino acids, the building blocks of proteins, that make up myelin basic protein (MBP), a major component of the myelin sheath.

Copaxone was first discovered when researchers were seeking a way to induce an MS-like autoimmune response in animal models. However, research first published in the 1970s showed that, contrary to expectations, treating mice with the compound actually prevented the disease from developing. This accidental finding led to Copaxone being developed as a therapy for MS.

The exact mechanisms of how Copaxone work in MS remain poorly understood. Broadly, the medication is thought to modulate the activity of a number of different types of immune cells — particularly T-cells and antigen-presenting cells (APCs) — to induce a less inflammatory state, thereby lessening the inflammatory attack that drives MS. Some studies suggest that Copaxone also directly acts on nerve cells to help protect them from damage.

Copaxone in clinical trials

The key clinical trial that led to Copaxone’s approval for marketing was carried out in the 1990s. The randomized, double-blind, placebo-controlled Phase 3 trial enrolled 251 patients with RRMS,  who received either Copaxone (20 mg daily, via an under-the-skin or subcutaneous injection) or a placebo daily, for two years.

The initial results, published in 1995, showed that participants given Copaxone experienced significantly fewer MS relapses, by 29%, over the course of the trial. The results also suggested that Copaxone-treated participants were significantly more likely than those given a placebo to experience an easing of disability, as measured by the Expanded Disability Status Scale (EDSS). By contrast, participants given a placebo were more likely to experience worsening disability.

Following the original placebo-controlled study, participants had the option to enter an open-label extension trial, in which all patients received the active medication and were monitored for safety and efficacy. Results showed that, after 10 years of treatment, the majority of patients (62%) still on Copaxone had EDSS scores that either were stable or had improved. Additionally, while participants had reported slightly more than one relapse per year on average before starting treatment, after a decade on Copaxone, participants were, on average, only experiencing one relapse every five years.

Another Phase 3 trial, called PreCISe (NCT00666224), enrolled 481 people with CIS who were randomly selected to receive daily Copaxone (20 mg) or a placebo for up to three years. Copaxone significantly lowered the risk of progression to clinically definitive MS by about 45%, the results showed.

More recently, Teva sponsored a randomized Phase 3 trial, called GALA (NCT01067521), to investigate the effectiveness of a higher dose of Copaxone. Specifically, it assessed a dosage of 40 mg three times weekly instead of 20 mg daily. The trial recruited 1,404 RRMS patients worldwide, who were randomly assigned to receive the less frequent dosing regimen of Copaxone or a placebo for one year, with the option to then enroll in an open-label extension study. Results indicated that the higher dose formula had a similar safety and efficacy profile to the original formulation, and follow-up data at seven years continued to indicate that the higher dosage could lessen relapse rates and delay disability progression. 

Other information

Copaxone is administered via subcutaneous (under-the-skin) injection. Two dosages are approved: 20 mg daily, or 40 mg three times per week.

The most common side effects associated with Copaxone in clinical trials include injection site reactions, vasodilatation — a widening of blood vessels, leading to a drop in blood pressure — rash, shortness of breath, and chest pain.

The medication carries warnings for chest pain and for reactions after injection, which may include flushing, chest pain, palpitations or racing heart, anxiety, throat constriction, shortness of breath, and/or hives. These reactions usually resolve on their own in time.

Tissue damage to the skin can occur, so it’s important that people using Copaxone know how to properly administer the medication, and injection sites should be rotated to avoid injecting the same spot over and over again. The medication also may modify immune responses.

Copaxone should not be used in people who are allergic to the medication or its components.

Copaxone has not been rigorously studied during pregnancy or while breastfeeding, though available data indicate that the medication is largely safe in both situations.

 

Last updated: Jan. 25, 2022, by Marisa Wexler MS

 


Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.

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