Copaxone: Higher doses, less-frequent dosing get FDA nod

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.

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.

Benefits and side effects

“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 should be available to patients now.

Patient assistance

With the patent on its original Copaxone formulation slated to expire in May, Teva has a strong motivation to help as many patients as possible to make the switch to the new product.

Patients can obtain guidance from their physicians, or they can call Teva’s Shared Solutions patient support center (800- 887-8100) with requests. 

Teva says it has retuned its Shared Solutions  center to better assist Copaxone patients as they make the transition to the new formulation. In addition, the center provides 24/7 nurse support, financial and benefits investigation, and identification of pharmacy distribution options that will give patients financial and physical access to Copaxone.

Shared Solutions also provides free injection training as well as ongoing compliance and adherence support services.