Glatiramer acetate 40 mg/ml: A review of the results of GALA and GLACIER clinical studies

Abstract

Multiple sclerosis (MS) is a demyelinating disease of the CNS, which affects mainly young able-bodied people; in this connection the problem of MS treatment assumes particular relevance. The paper reviews the main GALA (Glatiramer Acetate Low-frequency Administration) and GLACIER (Glatiramer Acetate low frequenCy safety and patient ExpeRience) clinical studies of subcutaneous glatiramer acetate (GA) 40 mg/ml three times per week (TIW). The results of the Phase III GALA multicenter randomized placebo-controlled parallel-group study of GA 40 mg injections administered less frequently (TIW) were published in 2013. The study involved 142 centers from 17 countries, including 17 Russian centers. The GALA study proved the efficacy, safety, and good tolerability of GA 40 mg TIW in patients with relapsing-remitting MS (RRMS). The safety profile of GA 40 mg was completely consistent with the well-known profile of GA 20 mg. The new GLACIER study was initiated to evaluate the efficiency and tolerability of treatment with GA 40 mg TIW versus GA 20 mg every day. This study confirmed that the tolerability profile of therapy with GA 40 mg TIW was better than that of GA 20 mg every day in patients with RRMS. GA 40 mg/ml TIW was approved for use in the USA, the United Kingdom, and a number of European countries for the treatment of patients with RRMS. In the Russian Federation, GA 40 mg was approved for use in September 2015.