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Phase III Data Announced for Glatiramer Acetate in Relapsing-Remitting MS
Relapse rate significantly reduced versus placebo (Oct. 10)
On October 10, Teva Pharmaceutical Industries Ltd., based in Israel, announced data from its phase III Glatiramer Acetate Low-Frequency Administration (GALA) trial. The GALA study was designed to evaluate the efficacy, safety, and tolerability of an investigational dosing regimen of glatiramer acetate (GA), the therapeutic agent in Copaxone (glatiramer acetate injection), which is indicated for the treatment of relapsing-remitting multiple sclerosis (RRMS).
Study results will be presented at the 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Lyon, France during a late-breaking news session on October 13.
In the GALA study — a 1-year randomized, double-blind, placebo-controlled trial — GA 40 mg/1 mL significantly reduced the annualized relapse rate (ARR) by 34.4% (P < 0.0001) versus placebo. In addition, a significant 34.4% reduction in the cumulative number of new and enlarging T2 lesions (P < 0.0001) and a significant 44.8% reduction in the cumulative number of gadolinium-enhancing (GdE) lesions (P < 0.0001) were observed in patients treated with GA 40 mg/1 mL versus placebo. At 12 months, there was no significant difference in the percent change in brain volume between GA and placebo. Discontinuation rates among the GA and placebo cohorts were comparable.
GA 40 mg/1 mL demonstrated a favorable safety and tolerability profile. The overall frequency of adverse events was comparable to that observed in the placebo group. The most commonly reported adverse events were injection-site reactions, headaches, and nasopharyngitis.
Copaxone (glatiramer acetate injection) is indicated to reduce the frequency of relapses in RRMS, including patients who have experienced a first clinical episode and have magnetic resonance imaging (MRI) features consistent with multiple sclerosis.
The most common side effects of Copaxone are redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain.
For more information, visit the Teva Pharmaceuticals Web site.