Copaxone® (glatiramer acetate)
Parent company: Teva Neuroscience, Inc.
- Given through daily subcutaneous injections; dosage is 20 mg.
- Approved for RRMS.
- It has been shown to significantly reduce the annual relapse rate in relapsing-remitting individuals.
- Copaxone is a synthetic protein that mimics myelin basic protein, a key component of the myelin sheath that is damaged in MS. It appears to block immune system T cells that damage myelin, and may decrease inflammation by shifting the balance among T-cell subtypes, as well as other effects.
- Data is now available for 15 years of Copaxone® treatment. Approximately one-third of patients experienced disease progression, but more than 80 percent remain ambulatory without mobility aids. This group will continue to be followed to 20 years.
- The Phase III, 36-month PreCISe study has shown a successful delay in the conversion of clinically isolated syndrome (CIS) to clinically definite MS (CDMS), as well as a reduction in MRI activity. Evidence suggests that the mechanism of action may include a neuroprotective component that prevents damage to axons. It also may induce lymphocytes to produce factors that enhance the survival of cells that produce myelin.
- An Austrian study indicated that a switch from interferon beta treatment to Copaxone was beneficial for individuals who discontinued interferon treatment because of a lack of effectiveness, whereas those who transferred due to side effects showed no substantial change on Copaxone.
- Preliminary evidence suggests that long-term maintenance treatment with glatiramer acetate treatment following immunosuppressive therapy with Novantrone may be effective and well tolerated for individuals with rapidly progressive MS and may stabilize the disease.
- Combination and Comparative studies: The COMBI Rx trial is still ongoing, and is comparing the combination of Avonex plus Copaxone to Copaxone alone and Avonex alone.
- A Phase II study of Copaxone taken with oral minocycline found that the combination reduced the number of new and active lesions. The two drugs were also reported to be safe and well tolerated when taken concurrently.
- A trial to study the effect of combining Copaxone and estriol (a naturally occurring estrogen hormone) in RRMS on relapse rate is currently recruiting. It will evaluate relapse rate, severity of relapses, and changes in the EDSS.
- A study of prednisone (a steroid) in 500 relapsing MS patients treated with Copaxone is ongoing. The trial will evaluate changes in brain volume after three years as its primary outcome.