FDA approves Teva's sNDA for three-times-a-week COPAXONE 40mg/mL

Jan 28 2014

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has approved the Company's supplemental new drug application (sNDA) for three-times-a-week COPAXONE^® 40mg/mL, a new dose of COPAXONE^®. This new formulation will allow for a less frequent dosing regimen administered subcutaneously 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 availability of three-times-a-week COPAXONE^® 40 mg/mL is a significant advancement for patients as they now have the option of effective and safe treatment with COPAXONE^®, while reducing the number of injections by 60 percent," said Omar Khan, M.D., Professor of Neurology and Chair of the Department of Neurology, Wayne State University School of Medicine, Detroit, MI. "Patients in the U.S. can now benefit from an improved dosing regimen without compromising the known benefits of COPAXONE^®."

The FDA approval is based on data from the Phase III Glatiramer Acetate Low-Frequency Administration (GALA) study 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 MS.

"For more than 20 years, Teva has pursued its multiple sclerosis research with the goal of providing effective, safe and tolerable therapies for MS patients," said Larry Downey, President, North America Specialty Medicines. "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. Today we are proud to continue to deliver on that investment by offering the freedom to dose three-times-a-week with COPAXONE^® 40 mg/mL."

Three-times-a-week COPAXONE^® 40mg/mL 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, three-times-a-week 40mg/mL formulation. Patients may call their doctors or Teva's Shared Solutions^® (1-800-887-8100) 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.