August 29, 2016
Health Canada approves three-times-a-week Copaxone 40mg/mL for the management of relapsing-remitting MS
Health Canada has recently approved Teva Pharmaceutical Industries Inc. three-times-a-week Copaxone® (glatiramer acetate) 40mg/mL injection. The new formulation of Copaxone provides a less frequent dosing schedule option for people living with relapsing remitting MS. Once-daily Copaxone 20mg/mL injection has been on the Canadian market since 1997 and will continue to be available.
Three-times-a-week Copaxone 40mg is expected to be available to people living with relapsing-remitting MS later this fall. The Health Canada product monograph has been updated to include both formulations of Copaxone. Each dose of Copaxone® 40 mg/mL is injected under the skin at least 48 hours apart. At this time, the new formulation Copaxone 40mg is only approved for relapsing-remitting MS, unlike its predecessor, Copaxone 20mg, that is also approved for the treatment of a first neurological event in people who are at risk of developing clinically definite MS.
Health Canada’s approval was primarily based on data from the Phase III Glatiramer Acetate Low-Frequency Administration (GALA) study, which was designed to evaluate the safety and efficacy of Copaxone 40mg. GALA was a double-blind, placebo-controlled, multinational trial with more than 1,400 participants living with RRMS randomized in a 2:1 ratio to receive either Copaxone 40 mg/mL or a mock drug (placebo) three times a week for 12 months. Results of the GALA study concluded that Copaxone 40mg/mL met its clinical endpoint (34% decrease in annual relapse rate compared with placebo) and imaging endpoints (reduction in new or enlarging brain lesions compared with placebo) after 6 and 12 months.
During the GALA trial, the adverse effects were consistent with the known adverse effects of Copaxone 20mg. The most common side effects are skin redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain.
The approval of three-times-a-week Copaxone provides another option for people with MS who are seeking treatment. Having a range of treatment options available enables individuals to select an injection schedule that accommodates their needs and lifestyles. Selecting an MS therapy should be done in consultation with a health care team. The MS Society of Canada will provide updates on availability and public coverage of three-times-a-week Copaxone as they become available.
Full drug information will be available on the MS Society website shortly.