Teva Pharmaceutical Industries Ltd. announced top-line results from a phase III study designed to assess the efficacy, safety and tolerability of glatiramer acetate (GA) 40mg as compared to the approved Copaxone 20mg in the treatment of relapsing-remitting multiple sclerosis (RRMS). The 40mg dose did not demonstrate increased efficacy in reducing the relapse rate; however, the higher dose maintained the favourable safety and tolerability profile of Copaxone 20mg.
Seventy-eight per cent (78%) of Copaxone 20mg treated patients remained relapse-free throughout the study. Moreover, patients that completed one year of treatment with Copaxone 20mg experienced a very low annualized relapse rate of 0.27. This robust effect was also reflected in a remarkable reduction of inflammatory activity as measured by MRI.
"While the trial did not demonstrate an enhanced efficacy at the higher dose level, the study reaffirms that Copaxone 20mg, the leading multiple sclerosis therapy, remains the optimal treatment dose with unmatched long term efficacy confirmed over 10 years," said Moshe Manor, group vice president - global innovative resources. "Teva is committed to ongoing research in the field of multiple sclerosis and will continue to move forward towards providing additional treatment options to multiple sclerosis patients".
Teva will continue to analyze the study results to better understand the effect of GA 40mg on patients. The company is also evaluating the use of GA for additional indications.
Current data suggest Copaxone (glatiramer acetate injection) is a selective MHC (Major Histocompatability Complex) class II modulator. Copaxone is indicated for the reduction of the frequency of relapses in RRMS. Copaxone is very well tolerated and the most common side effects of Copaxone are redness, pain, swelling, itching, or a lump or an indentation at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety and muscle stiffness.
Copaxone is now approved in 51 countries worldwide, including the United States, all European countries, Canada, Mexico, Australia and Israel. In Europe, Copaxone is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. In North America, Copaxone is marketed by Teva Neuroscience, Inc.