July 7, 2008
Teva’s Phase III Multiple Sclerosis Study Trial Fails to Demonstrate Increased Efficacy
Teva Pharmaceutical Industries has reported results from a Phase III study designed to assess the efficacy, safety and tolerability of glatiramer acetate 40mg as compared to the approved Copaxone 20mg in the treatment of relapsing-remitting multiple sclerosis.
The 40mg dose did not demonstrate increased efficacy in reducing the relapse rate; however, the higher dose maintained the favorable safety and tolerability profile of Copaxone 20mg.
Approximately 70-80% (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 magnetic resonance imaging.
Teva will continue to analyze the study results to better understand the effect of glatiramer acetate (GA) 40mg on patients. The company is also evaluating the use of GA for additional indications.
Moshe Manor, group vice president of global innovative resources at Teva, said: "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."