Israel-based 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 glatiramer acetate injection indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS).
According to the company, the new formulation will allow for a less frequent dosing regimen given subcutaneously for patients with relapsing forms of MS.
As well as the newly approved dose, daily PAXON 20 mg/ml will continue to be available, the company said.
Wayne State University School of Medicine professor of neurology Omar Khan said the availability of three-times-a-week PAXON 40mg/ml is a significant advancement for patients and reduces the number of injections by 60%.
"Patients in the US can now benefit from an improved dosing regimen without compromising the known benefits of COPAXONE," Khan added.
The approval is based on data secured from the Phase III Glatiramer Acetate Low-Frequency Administration (GALA) study carried out in more than 1,400 patients.
The trial showed that a 40mg/mL dose of COPAXONE administered subcutaneously three-times-a-week reduced relapse rates at 12 months and demonstrated a favourable safety and tolerability profile in patients with relapsing-remitting MS.
Teva president of North America specialty medicines Larry Downey said: "We have progressively invested in the innovation of COPAXONE in an effort to understand the needs and to ease the burden of patients who live with relapsing forms of MS every day."
The company said that the three-times-a-week COPAXONE 40mg/mL is available for shipping to distribution outlets immediately, and will be available to patients within days.
The 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.
Image: COPAXONE is an immunomodulator drug currently used to treat multiple sclerosis. Photo: courtesy of Marvin 101.