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FDA Approves Three-Times-A-Week Copaxone

Today Teva Pharmaceuticals Industries Ltd. received approval from the US Food and Drug Administration to market a long-acting version of Copaxone (glatiramer acetate) for the treatment of relapsing forms of multiple sclerosis.

The new 40mg/mL formulation of Copaxone will provide patients with a less frequent, three-times-a-week dosing regimen. Approval was based on results from the Phase III Glatiramer Acetate Low-Frequency Administration (GALA) study, which included more than 1,400 patients with relapsing-remitting MS. It was shown that the 40mg/mL dose of Copaxone significantly reduced relapse rates at twelve months when administered subcutaneously three-times-a-week. Copaxone 40mg/mL demonstrated a favorable safety and tolerability profile.

Teva expects the new 40mg/mL dose of Copaxone to be available for patient use within days. The current 20mg/mL of Copaxone, will still be available for daily use, although generic options are anticipated in the coming months.

Teva gets FDA approval of three-times-a-week Copaxone. The Pharma Letter. Available at: Accessed January 29, 2014