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Generic Copaxone (Glatiramer) May Lower MS Drug Costs

generic Copaxone for MS

Results of a Phase III clinical trial of the multiple sclerosis (MS) drug glatiramer acetate, the generic of the brand Copaxone, indicate the two medications have equivalent efficacy and safety. If approved, availability of this first generic MS drug on the market will mean lower costs for patients.

Copaxone is the brand name of the injectable MS drug made by Teva Pharmaceutical Industries Ltd. The drug is currently available in both a once-daily and three-time-a-week formulation, the latter of which was approved by the Food and Drug Administration (FDA) in January 2014.

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Glatiramer acetate is a man-made protein that was developed to simulate a basic protein found in myelin, the protective coating on nerve fibers in the central nervous system. The drug appears to help interfere with the T-cells that damage the myelin.

Use of Copaxone is for individuals with the most common type of MS, relapsing-remitting MS. It also is approved for people who have experienced clinically isolated syndrome and have magnetic resonance imaging proof that is consistent with MS.

The Copaxone and glatiramer study
The ongoing GATE (Glatiramer Acetate clinical trial To assess Equivalence with Copaxone) is the only Phase III study so far that has used generic Copaxone (Synthon’s glatiramer acetate) and shown equivalent safety and efficacy with the Teva drug. The trial consists of a nine-month, double-blind study followed by 15-month open-label segment, which is the portion currently running.

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During the nine-month study, 796 individuals with active relapsing-remitting MS were randomly assigned to daily injections of either 20 mg/ml glatiramer acetae, 20 mg/ml Copaxone, or placebo. That segment of the trial showed

  • brain lesions (as seen on magnetic resonance imaging) to be reduced equally in the glatiramer acetate and Copaxone groups
  • both treatment groups demonstrated significant reductions when compared with placebo
  • patients in both treatment groups tolerated the drugs well and reported similar side effects

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Now, during the 15-month segment of the trial, patients in both the Copaxone and placebo groups have switched to the Synthon drug while those originally in the glatiramer acetate group have remained so.
The purpose of this portion of the trial is to confirm the safety and efficacy of taking the generic drug for a prolonged period and to provide proof that it is safe to switch from Copaxone to the generic version.

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What’s to come
If the second segment of the Phase III trial goes as planned, the final journey toward approval in Europe and the United States by the Food and Drug Administration (FDA) will ensue. Synthon already took steps back in November 2011 when it submitted an Abbreviated New Drug Application for its product to the FDA.

In addition to glatiramer acetate, Synthon also has several other generic MS drugs in the pipeline.
Currently, Copaxone costs about $30,000 to $60,000 per patient annually. According to Synthon’s chief executive officer Jacques Lemmens, availability of a generic version of the drug means it “will become more affordable, thereby allowing more MS patients around the world to have access to this medication.”

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Multiple Sclerosis Society
Teva Pharmaceutical

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