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Saturday, September 5, 2015

3 Times a Week Dose Copaxone for Relapsing MS Receives Positive Outcome in Europe

Israel-based biopharmaceutical company Teva Pharmaceutical Industries Ltd. announced last week that its thrice-weekly COPAXONE® (glatiramer acetate)40mg/ml treatment for relapsing-remitting multiple sclerosis (RRMS) has received positive results in a decentralized procedure. The favorable outcome proceeds a Positive Assessment Report from the United Kingdom, the Reference Member State’s Medicines and Healthcare Products Regulatory Agency (MHRA), and all Concerned Member States (CMS) in Europe that had participated in the procedure. The company is anticipating the granting of national marketing authorizations for Copaxone® very soon.
3 Times a Week Dose Copaxone for Relapsing MS Receives Positive Outcome in Europe
The Reference Member State’s Positive Assessment Report was based on the impressive findings from Teva’s Phase III Glatiramer Acetate Low-Frequency Administration (GALA) study, which involved over 1,400 patients. Results revealed patients dosed three times a week with Copaxone 40 mg/mL experienced significantly reduced relapse rates at 12 months, and a favorable safety and tolerability profile.
Dr. Rob Koremans, the President and CEO of Global Specialty Medicines at Teva Pharmaceutical, said the company is eager to bring this proven, improved formulation of Copaxone to patients living with RRMS to Europe. They are projecting the drug’s availability in Europe to begin as soon as Q1 2015 in Germany, the Netherlands, and Denmark, with other EU countries following suit as 2015 progresses.


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