FDA Approves New Copaxone 40mg Strength

Teva announced the FDA approval of Copaxone (glatiramer acetate injection) 40mg/mL, a new strength of Copaxone injection. This new formulation will allow for a reduced number of injections given in a patient’s regimen.

Copaxone is indicated to reduce the frequency of relapses in patients with relapsing-remitting multiple sclerosis, including those who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis.

The new approval is based on a Phase 3 Glatiramer Acetate Low-Frequency Administration (GALA) study of over 1,400 patients. Results showed that a subcutaneously administered dose of Copaxone 40mg/mL delivered three times weekly significantly reduced relapse rates at 12 months.

Copaxone 40mg/mL is available as single-dose prefilled syringes in 12-count cartons. The existing Copaxone 20mg/mL will continue to be available as single-dose prefilled syringes in 30-count cartons.

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