Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced today that data from the Glatiramer Acetate Low-frequency Administration (GALA) study, published in the Annals of Neurology, show that a 40mg/ 1mL dose of COPAXONE ® (glatiramer acetate injection) administered subcutaneously three times per week significantly reduced relapse rates at 12 months and demonstrated a favorable safety and tolerability profile in patients with relapsing-remitting multiple sclerosis (RRMS). Currently, the approved dose for COPAXONE ® is 20mg/ 1mL, which is a once a day subcutaneous injection.
The GALA study, a multinational, phase III, double blind, placebo controlled study, was designed to evaluate the efficacy, safety and tolerability of an investigational 40mg/ 1mL dose of GA given three times a week over a period of 12 months for the treatment of RRMS.
The published data show that glatiramer acetate (GA) 40mg/ 1 mL injections administered three times a week reduced annualized relapse rates by 34.0% (p<0.0001), reduced the cumulative number of new and enlarging T2 lesions by 34.7% (p<0.0001) when measured at six and 12 months, and the cumulative number of gadolinium enhancing lesions by 44.8% (p<0.0001) when measured at six and 12 months, as compared to placebo in patients with RRMS.
“We are pleased with the positive data of the GALA study which may lead to meaningful benefits for RRMS patients,” said lead study author Omar Khan, M.D., Professor of Neurology and Chair of the Department of Neurology, Wayne State University School of Medicine, Detroit, MI. “COPAXONE ® 40mg/ 1 mL given three times a week demonstrated a favorable safety and tolerability profile, with the overall frequency of adverse events comparable to those seen in the placebo group.”The most common adverse event in the GA group was injection site reactions (35.5% with GA vs. 5.0% with placebo).