Higher-Dose, Lower-Frequency Glatiramer Effective in MS

Susan Jeffrey

June 14, 2012

June 14, 2012 — Topline results of a phase 3 trial comparing a new higher dose of glatiramer acetate (Copaxone, Teva Pharmaceutical Industries Ltd) with placebo show the drug significantly reduced the annualized relapse rate and was safe and well tolerated in patients with relapsing-remitting multiple sclerosis (MS).

The Glatiramer Acetate Low-Frequency Administration (GALA) trial investigated the effect of increasing the drug dose to 40 mg/1 mL injection from the currently approved dose of 20 mg/1 mL, while reducing the dosing frequency from once daily to 3 times per week.

The GALA trial was a 1-year randomized, double-blind, placebo-controlled study that enrolled more than 1400 patients from 155 multinational sites, a statement from Teva released today notes. An open-label extension phase is ongoing.

Results at 12 months showed the new 40 mg/1 mL dose significantly reduced the annualized relapse rate by 34.4% vs placebo (P < .0001).

"Initial analysis of the data indicates that secondary clinical endpoints were achieved, with the exception of reductions in brain atrophy," the statement notes.

The most common adverse events were injection site reactions, headaches, and nasopharyngitis, and the overall frequencies of adverse events were similar to those seen in the placebo group, the company reports.

Further analyses are underway, and detailed results "will be presented to the scientific community in the near future. Teva plans to work with health authorities to determine next steps," the release states.

"We are pleased with the results of this study that show the potential of 40 mg/1 ml glatiramer acetate to offer patients an effective and safe treatment option with [glatiramer acetate] using a more convenient dosing regimen," said Serge Stankovic, senior vice president of clinical research, global R&D at Teva. "We remain focused on the continued research and development of products aimed at improving the treatment experience for patients with MS."

Glatiramer acetate is approved in the United States, as well as 50 countries worldwide, for the reduction of frequency of relapses in relapsing-remitting MS, including patients who have experienced a first clinical episode and have features on imaging consistent with MS. The most common side effects are redness, pain, swelling, itching, or a lump at the site of injection; flushing; rash; shortness of breath; and chest pain.

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