FDA approves higher dose, less-frequent dosing regimen for Copaxone

January 30, 2014

FDA approved a 40 mg/mL dose of glatiramer acetate injection (Copaxone, Teva Pharmaceutical Industries Ltd.) to be used three times a week for patients with relapsing forms of multiple sclerosis (MS). This new higher-dose formulation will allow for a less-frequent dosing regimen.

FDA approved a 40 mg/mL dose of glatiramer acetate injection (Copaxone, Teva Pharmaceutical Industries Ltd.) to be used 3 times a week for patients with relapsing forms of multiple sclerosis (MS). This new higher-dose formulation will allow for a less-frequent dosing regimen.

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.

“This product offers the advantage of 60% fewer injections and is priced just below parity with Copaxone 20 mg/mL,” said Teva’s Nancy Leone, communications director, global specialty medicines. “Given the clear patient benefit of Copaxone 40 mg/mL, our discussions with payers have been productive as they are interested in providing appropriate access to MS patients.”

FDA based its approval on data from the phase 3 Glatiramer Acetate Low-Frequency Administration (GALA) study of more than 1,400 patients, which showed that a 40 mg/mL dose of Copaxone administered subcutaneously 3 times weekly 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 are redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain.

The new Copaxone formulation is available for shipping to distribution outlets immediately, and will be available to patients within days. Teva’s Shared Solutions patient support center has been scaled to support current patients as they transition to the new formulation. Patients may call their physicians or Teva’s Shared Solutions (800) 887-8100 and make a request. In addition, Shared Solutions provides 24/7 nurse support, financial and benefits investigation as well as identification of pharmacy distribution options to enable financial and physical access to Copaxone. Shared Solutions also provides free injection training as well as ongoing compliance and adherence support services.