The Phase III GALA trial found lower multiple sclerosis relapse rates when higher Copaxone doses are injected three times weekly rather than daily.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) announced today that Phase III data from the Glatiramer Acetate Low-frequency Administration (GALA) study show that a 40 mg/1mL dose of Copaxone injected three times per week significantly reduced relapse rates at 12 months. The data, published in the Annals of Neurology, also demonstrated a favorable safety and tolerability profile in patients with relapsing-remitting multiple sclerosis (RRMS). Currently, the approved dose for Copaxone is a daily 20mg/1mL injection.
The GALA study, a multinational, phase III, double blind, placebo controlled study, showed that 40mg Copaxone injections three times a week reduced annualized relapse rates by 34%, reduced the cumulative number of new and enlarging T2 lesions by 34.7% when measured at six and 12 months, and the cumulative number of gadolinium enhancing lesions by 44.8% when measured at six and 12 months, as compared to placebo in patients with RRMS.
Wayne State University School of Medicine Professor of Neurology and Chair of the Department of Neurology, Dr. Omar Khan said, “We are pleased with the positive data of the GALA study which may lead to meaningful benefits for RRMS patients. Copaxone 40 mg/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.”
Published by Globes [online], Israel business news – www.globes-online.com – on July 1, 2013