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news.Teva Pharmaceutical Industries has reported positive data from the Phase III Glatiramer Acetate Low-Frequency Administration (GALA) study of glatiramer acetate (GA), the therapeutic agent in Copaxone (glatiramer acetate injection).
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The trial was designed to examine the efficacy, safety and tolerability of glatiramer acetate 40mg/ml injection administered three times a week compared to placebo in over 1,400 patients with relapsing-remitting multiple sclerosis.
Glatiramer acetate 40mg/ml injection administered three times a week significantly reduced annualised relapse rates by 34.4% (p<0.0001) compared to placebo in over 1,400 patients with relapsing-remitting multiple sclerosis.
Teva Pharmaceutical Industries chief scientific officer and Global R&D president Dr. Michael Hayden said, "The GALA study demonstrates Teva’s ongoing commitment to the research and development of products aimed at meeting the specific needs of the RRMS community."
Patients treated with GA 40mg/1 ml versus placebo have shown significant 34.4% reduction in the cumulative number of new and enlarging T2 lesions and a significant 44.8% reduction in the cumulative number of gadolinium-enhancing legions.
The study observed no significant difference in percent change of brain volume between GA and placebo. Discontinuation rates among the GA and placebo patient cohorts were similar.
GA 40mg/1ml demonstrated a favourable safety and tolerability profile and the overall frequency of adverse events was similar to those observed in the placebo group.