Glatiramer acetate, manufactured and marketed under the name Copaxone by Teva Pharmaceuticals, is an immunomodulatory injectable drug used for combating the symptoms of multiple sclerosis (MS) in patients. It is a polymer of four basic amino acids found in myelin sheaths of nerve fibers, and has been shown in studies to be effective in reducing the frequency of relapse in patients with remitting or relapsing MS.
History of Copaxone
Approval in the U.S. was granted by the U.S. Food and Drug Administration (FDA) in 1996 and in the U.K. in August 2000. Since then, Copaxone has been approved for marketing in over 50 countries worldwide.
The immunomodulatory properties of the drug were proven initially in mice models, where Copaxone was found to block the induction of experimental autoimmune encephalitis (EAE). Clinical trials testing the safety, efficacy, and tolerability of the drug in healthy hosts and patients alike have shown that despite the drug being safe for patients and effective in reducing frequency of relapses, it was not of benefit in reducing or stopping disease progression. This has been highlighted in several reviews between 2004 and 2007. The FDA also approved the drug in March 2009 for clinically isolated syndrome, where administration of the intravenous formulation reduced risks of relapses and progression to clinically definite MS after the first episode. In April 2015, the agency approved the first major generic version of Copaxone, to be marketed by Sandoz.
How Copaxone Works
The mode of action for Copaxone is not entirely understood, but experiments have shed light on the possibility of the drug’s ability to lure autoimmune responses toward itself and reduce damage to the myelin sheaths. This is mainly owing to the chemical composition of the drug, which consists of the four basic myelin sheath amino acids: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine. This helps in mimicking the myelin sheath, and prevents the inflammatory responses from damaging the actual nerve coverings. Intravenous administration of the drug also helps in converting the population of pro-inflammatory Th1 cells to that of anti-inflammatory Th2 cells, reducing the rates of exacerbations in patients.
Normal dosage of the drug ranges from 20 mg per mL once daily, to 40 mg per mL three times a week and at least 48 hours apart from each other. The most common side effects reported by patients include redness and rashes, flushing, shortness of breath, anxiety, and mild flu-like symptoms. However, people with cardiac problems or severe renal or hepatic complications should consult an expert before resorting to Copaxone.
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