The FDA ( Food and Drug Administration ) has approved the supplemental new drug application ( sNDA ) for three-times-a-week Copaxone ( Glatiramer acetate ) 40mg/mL. This new formulation will allow for a less frequent dosing regimen administered subcutaneously for patients with relapsing forms of multiple sclerosis.
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 approval is based on data from the phase III GALA ( Glatiramer Acetate Low-Frequency Administration ) trial of more than 1400 patients, which showed that a 40 mg/mL dose of Copaxone administered subcutaneously three-times-a-week significantly reduced relapse rates at 12 months and demonstrated a favorable safety and tolerability profile in patients with relapsing-remitting multiple sclerosis.
The most common side effects of Copaxone are redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain.
Important safety information
Patients allergic to Glatiramer acetate or Mannitol should not take Copaxone.
Some patients report a short-term reaction right after injecting Copaxone. This reaction can involve flushing ( feeling of warmth and/or redness ), chest tightness or pain with heart palpitations, anxiety, and trouble breathing. These symptoms generally appear within minutes of an injection, last about 15 minutes, and go away by themselves without further problems.
Chest pain may occur either as part of the immediate postinjection reaction or on its own. This pain should only last a few minutes. Patients may experience more than one such episode, usually beginning at least one month after starting treatment.
A permanent indentation under the skin ( lipoatrophy or, rarely, necrosis ) at the injection site may occur, due to local destruction of fat tissue. Patients should follow proper injection technique and inform their doctor of any skin changes. ( Xagena )
Source: Teva Pharmaceutical, 2014