FDA approves three times a week Copaxone for MS- Teva

Teva Pharmaceutical Industries Ltd. has announced that the 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 favourable safety and tolerability profile in patients with relapsing-remitting MS.