Teva announced Thursday that a late-stage trial investigating a new dosing regimen for Copaxone (glatiramer acetate) in patients with relapsing-remitting multiple sclerosis (RRMS) met its main goal compared to placebo. The company noted that in the GALA study, Copaxone was dosed at 40 milligrams three times a week, which is higher than the currently marketed daily 20-millgram dose.
The one-year trial randomised more than 1400 patients with RRMS to receive either Copaxone dosed via the new schedule or placebo. Teva said that the study's primary endpoint was achieved, with top-line results showing that Copaxone significantly reduced the annualised relapse rate by 34.4 percent versus placebo. The company added that based on initial analysis of the data, secondary study goals were also met, except a reduction in brain atrophy, while the new dosing regimen maintained a "favourable safety and tolerability profile."
Teva noted that following the initial trial, there will be an ongoing open-label extension, adding that further analyses of the study are ongoing, with additional results expected to be released in the near future. Teva said it will also work with health authorities to determine the next steps.
Copaxone is approved in more than 50 countries for the reduction of the frequency of relapses in RRMS, including patients who have experienced a first clinical episode and have MRI features consistent with the disease.
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