Teva Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for its supplemental new drug application (sNDA) for three-times-a-week COPAXONE 40mg/mL, a new dose of COPAXONE.
COPAXONE (glatiramer acetate injection) is indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS)
The company said that the new formulation will allow for a less frequent dosing regimen given subcutaneously for patients with relapsing forms of MS.
In addition to the newly approved dose, daily COPAXONE 20 mg/mL will continue to be available, the company said.
The FDA approval is based on data from the Phase III Glatiramer Acetate Low-Frequency Administration (GALA) study conducted in over 1400 patients.
The trial showed that a 40mg/mL dose of COPAXONE given subcutaneously three-times-a-week reduced relapse rates at 12 months and demonstrated a favorable safety and tolerability profile in patients with relapsing-remitting MS.
According to the company, the three- times-a-week COPAXONE 40mg/mL is available for shipping to distribution outlets immediately, and will be available to patients within days.
Most common side effects of COPAXONE include redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain.