23 August 2016 - Teva Canada Innovation announced today that Health Canada has approved three-times-a-week Copaxone (glatiramer acetate) 40 mg/mL injection.

This new formulation of Copaxone will allow for a less frequent dosing regimen for patients with relapsing remitting multiple sclerosis (RRMS). In addition to the newly approved dose, daily Copaxone 20 mg/mL will continue to be available.

Three-times-a-week Copaxone 40 mg/mL is expected to become commercially available to patients, by prescription, later this fall. Patients throughout Canada will continue to benefit from Shared Solutions, a unique and personalized support program from Teva Canada Innovation available to anyone touched by MS including family members, friends, caregivers and health professionals.

Health Canada approval is based primarily on data from the Phase III Glatiramer Acetate Low-Frequency Administration (GALA) study, the largest Copaxone clinical trial to date, which included more than 1,400 patients.

Three-times-a-week Copaxone 40 mg/ml was approved by the U.S. FDA in January, 2014 and at the end of June 2016, approximately 61,500 patients were on Copaxone 40mg. In Europe, the MHRA and other EU member states issued a positive assessment report under the decentralized procedure in December 2014, and since launch, three-times-a-week Copaxone 40 mg/ml has been prescribed to more than 36,000 patients.

Read Teva Pharmaceuticals press release