Not sure why Teva has issued this given that there appears to be no benefit in 40mg Copaxone over 20mg.
Update on Copaxone FORTE Trial in Multiple Sclerosis 07 July 2008
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 percent (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 annualised 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 analyse 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.
About the Study
A randomized, double-blind study, designed to assess the efficacy, safety and tolerability of 40mg glatiramer acetate, as compared to the currently approved COPAXONE® (glatiramer acetate) 20mg dose. The study was conducted in 136 centers in North America, Argentina, Europe and Israel, and included 1,155 patients with RRMS. The trial’s primary clinical outcome measure was rate of confirmed relapses.
Source: Teva Pharmaceutical Industries Ltd