LYON, FRANCE—Data from a phase III trial support the efficacy of a new dosing regimen for Copaxone (glatiramer acetate) for patients with relapsing-remitting multiple sclerosis (MS).
Teva Pharmaceutical Industries released data from the Glatiramer Acetate Low-Frequency Administration (GALA) study, which was designed to evaluate the efficacy, safety, and tolerability of 40 mg/mL of glatiramer acetate three times weekly instead of the 20-mg/mL daily subcutaneous injection that has been the recommended dose for almost two decades.
In the GALA study, a one-year, randomized, double-blind, placebo-controlled trial, glatiramer acetate 40 mg/mL injected three times weekly significantly reduced annualized relapse rates by 34.4% versus placebo. The cumulative number of new and enlarging T2 lesions was significantly reduced by the same percentage. In addition, a significant 44.8% reduction in the cumulative number of gadolinium-enhancing lesions was observed in patients treated with the investigational dosing regimen. At 12 months, there was no significant difference in percentage change of brain volume between the glatiramer acetate-treated patients and those receiving placebo. Discontinuation rates among the two cohorts were comparable.
Glatiramer acetate in a dose of 40 mg/mL also showed a favorable safety and tolerability profile. The overall frequency of adverse events was comparable to that of the placebo group. The most common reported adverse events were injection-site reactions, headaches, and nasopharyngitis.
The drug maker released only top-line data at a press conference. Lead study author Omar A. Khan, MD, Professor and Interim Chair of the Department of Neurology and Director of the Multiple Sclerosis Clinical Research Center and Image Analysis Laboratory at Wayne State University School of Medicine in Detroit, will report detailed study results on October 13 in a late-breaking news session of the 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis.
—Glenn S. Williams