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Russia Approves Copaxone Treatment Three Times a Week for RRMS

October 19, 2015

Teva Pharmaceutical Industries Ltd., a leading global pharmaceutical company, recently announced the approval of a Marketing Authorization license by the Russian Ministry of Health for three-times-per-week Copaxone 40 mg/mL, a new dose of Copaxone, to treat patients with a diagnosis of relapsing-remitting multiple sclerosis (RRMS). This new Copaxone formulation will reduce the frequency of dose regimen for RRMS patients in Russia.

“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 in a press release. “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 approval of this injectable drug was based on the results of the phase 3 Glatiramer Acetate Low-Frequency Administration trial, which involved 1,400+ RRMS patients. This trial showed that 40mg/mL dosing of Copaxone administered subcutaneously 3 times a week, resulted in a huge reduction in relapse rates after a year. The study noted that this method is safer and more tolerable for the patient as well.