FDA approves 40 mg/mL Copaxone for�3 times a week
March 15, 2014
The U.S. Food and Drug Administration (FDA) has approved the three-times-a-week COPAXONE® 40mg/mL, a new dose of COPAXONE® on Jan 28, 2014. This new formulation will allow for a less frequent dosing regimen administered by injection for patients with relapsing forms of multiple sclerosis (MS). In addition to the newly approved dose, daily COPAXONE® 20 mg/mL will continue to be available.
The FDA approval is based on data from the Phase III Glatiramer Acetate Low-Frequency Administration (GALA) study of more than 1400 patients, which showed that a 40 mg/mL dose of COPAXONE® administered by injection three-times-a-week significantly reduced relapse rates at 12 months compared to placebo. It also demonstrated a favorable safety and tolerability profile in patients with relapsing MS.
The availability of three-times-a-week COPAXONE® 40 mg/mL is an advancement for patients as they now have the option of effective and safe treatment with COPAXONE®, while reducing the number of injections by 60 percent. Direct comparison of efficacy between the Copaxone 40 mg/ml three-times-a-week and 20 mg/mL daily injection treatment is not available. For patient who is currently on Copaxone 20mg/ml daily injection treatment or is considering the 40 mg/ml three-times-a-week Copaxone as their new DMT, they should discuss these two available Copaxone dosing options with their MS care provider to see if Copaxone 40 mg/ml three-times-a-week is a good choice for them.