New Dosing Regimen for Copaxone Submitted to FDA

Teva Pharmaceuticals Industries, Ltd., the makers of Copaxone® (glatiramer acetate), announced on May 30, 2013 that the United States Food and Drug Administration (FDA) had accepted a supplemental new drug application (sNDA) for Copaxone at a higher dose and reduced frequency. The present FDA-approved dose of Copaxone is 20 mg given daily via subcutaneous injection. The new dosing under review is double the concentration (40 mg) and is given three days per week (also via subcutaneous injection) versus every day. If FDA approved, a less-frequent treatment option for Copaxone may become available.

This new dosing regimen was studied in the multinational Phase III Glatiramer Acetate Low-frequency Administration (GALA) trial. As noted in MSAA’s most recent MS Research Update (published in March 2013), “The GALA trial was a randomized, placebo-controlled trial of Copaxone dosed at 40 mg given by subcutaneous injection three-times weekly versus placebo. Data from this trial were presented in Fall 2012. This three-times weekly dosing strategy of Copaxone reduced relapse rates by 34 percent compared with placebo, and reduced new MRI lesions by 35 percent. This is comparable with the expected efficacy of Copaxone given at the standard dose of 20 mg injected daily, and no new safety concerns were identified.”

Copaxone is one of 10 FDA-approved disease-modifying therapies for the long-term treatment of relapsing forms of MS. For more information on these medications, please visit the treatment section of MSAA’s website (

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Written by Susan Wells Courtney, MSAA Senior Writer and Creative Director
Reviewed by Jack Burks, MD, MSAA Chief Medical Officer