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FDA Approves Three-Times-a-Week Copaxone (Glatiramer Acetate) for MS Patients

New dose allows less frequent injections (January 28)

The FDA has approved three-times-a-week Copaxone (glatiramer acetate injection, Teva Pharmaceutical Industries Ltd.) 40 mg/mL for patients with relapsing forms of multiple sclerosis (MS).

In addition to the newly approved dose, daily Copaxone 20 mg/mL will continue to be available. The daily subcutaneous injection was approved in 1996.

The FDA’s approval was based on data from the phase III Glatiramer Acetate Low-Frequency Administration (GALA) trial in more than 1,400 patients. In this study, a 40 mg/mL dose of Copaxone administered subcutaneously three times per week significantly reduced relapse rates at 12 months and demonstrated a favorable safety and tolerability profile in patients with relapsing-remitting MS.

The most common side effects of Copaxone include redness, pain, swelling, itching, or a lump at the injection site, as well as flushing, rash, shortness of breath, and chest pain.

Source: Teva; January 28, 2014.

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