Pharmaceutical Business review

Teva’s multiple sclerosis drug tops comparative study

The US unit of Israeli drug maker Teva Pharmaceutical compared Copaxone to Betaferon, marketed by Chiron, Avonex, a Biogen Idec drug, and Serono’s Rebif treatment.

Copaxone produced a statistically significant greater reduction in annual relapse rates at 24 months after initiation of treatment versus pre-study rates. Additionally, a significantly higher percentage of patients remained on Copaxone for the duration of the study compared to the beta interferons, which Teva believes is a product of efficacy perception or lack of side effects.

The study evaluated 283 patients with relapsing-remitting multiple sclerosis (RRMS). By the sixth month of the study, all treatments produced statistically significant reductions in annualized relapse rates relative to baseline. By 12 months, Copaxone achieved a statistically greater relapse-rate reduction than Betaferon, and at 24 months after initiation of treatment, relapse-rate reductions were greater with Copaxone compared to all other treatments.

Relapse-rate reductions in this study were comparable to those previously reported in phase III placebo-controlled clinical trials with these agents at 24 months relative to baseline, supporting the validity of the observations and conclusions.

Current data suggest Copaxone (glatiramer acetate injection) is a selective MHC class II modulator. It is indicated for the reduction of the frequency of relapses in relapsing-remitting multiple sclerosis. The most common side effects of the drug are redness, pain, swelling, itching, or a lump at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.

Copaxone is now approved in 44 countries worldwide, including the US, Canada, Mexico, Australia, Israel, and all the European countries.