The FINANCIAL — Teva Pharmaceutical Industries Ltd. on October 8 announced that the Russian Ministry of Health has approved the Marketing Authorization license (MA) for three-times-a-week COPAXONE (glatiramer acetate injection) 40 mg/mL, a new dose of COPAXONE, for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS).
This formulation of COPAXONE will allow for a less frequent dosing regimen for patients with RRMS in Russia, according to Teva.
“For more than 20 years, Teva has been committed to safe and tolerable treatments options for patients with multiple sclerosis. The availability of three-times-a-week COPAXONE 40 mg/mL is a significant advancement for the multiple sclerosis patient community in Russia,” said Rob Koremans, MD, President and CEO of Global Specialty Medicines at Teva. “The new three-times-a-week COPAXONE 40 mg/mL is the same therapy that patients and physicians know and trust with almost 60 percent fewer injections per year compared to the current daily COPAXONE 20 mg/mL formulation. In the U.S., for example, more than 70 percent of patients currently receiving glatiramer acetate treatment are receiving the COPAXONE 40 mg/mL formulation.”
The Russian Ministry of Health approval was based primarily on data from the Phase III Glatiramer Acetate Low-Frequency Administration (GALA) study. In the GALA study, which included more than 1,400 patients, the 40 mg/ml dosage of COPAXONE administered subcutaneously three times per week significantly reduced relapse rates at 12 months and demonstrated a favorable safety and tolerability profile in patients with RRMS.
Daily COPAXONE 20 mg, approved in Russia in 2010, continues to be available in Russia.