The Russian Ministry of Health has authorised Teva Pharmaceutical Industries to market three-times-a-week Copaxone (glatiramer acetate injection) 40 mg/mL for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS).
The new formulation of Copaxone is anticipated to allow for a less frequent dosing regimen for patients with RRMS in the country.
Teva Global Specialty Medicines president and CEO Rob Koremans said: "The availability of three-times-a-week Copaxone 40 mg/mL is a significant advancement for the multiple sclerosis patient community in Russia.
"The new three-times-a-week Copaxone 40 mg/mL is the same therapy that patients and physicians know and trust with almost 60% fewer injections per year compared to the current daily Copaxone 20 mg/mL formulation.
"In the US, for example, more than 70 %of patients currently receiving glatiramer acetate treatment are receiving the Copaxone 40 mg/mL formulation."
The marketing authorisation license was primarily based on data obtained from the Phase III Glatiramer Acetate low-frequency administration study, where the 40 mg/ml dosage of Copaxone was administered subcutaneously to more than 1,400 patients three times per week.
The dosage is said to have significantly reduced relapse rates at 12 months, whilst also demonstrating a favourable safety and tolerability profile in patients with RRMS.
Daily Copaxone 20 mg continues to be available in Russia since it was approved in the country in 2010.
Copaxone is indicated for the treatment of patients with relapsing forms of multiple sclerosis, and is approved for sale more than 50 countries worldwide, including Russia, Canada, Mexico, Australia, Israel, the US, and all European countries.
Image: Syringe and box of Copaxone indicated for treatment of patients with relapsing forms of multiple sclerosis. Photo: courtesy of Mariusz Ch.