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.
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.
Copaxone is Teva’s only FDA-approved drug for multiple sclerosis, with the once-a-day formulation receiving approval in Europe in 2000. The three times a week 40 mg/ml formulation gives patients a more convenient treatment option in that it bundles improved efficacy in a more spaced-apart, subcutaneous dosing. Clinical studies have shown three-times-a-week Copaxone can maintain the benefits of the once-a-day formulation, with up to 60 percent fewer injections. The drug has already been prescribed to over 40,000 RRMS patients since its approval in the United States earlier in January 2014.
The President of Global R&D and Chief Scientific Officer at Teva, Michael Hayden, M.D., Ph.D., said: “Teva has been committed to the pursuit of MS research, and the development of COPAXONE®, for more than 20 years. We are proud to be able to bring to patients in Europe the option of this new, three-times-a-week-COPAXONE® 40 mg/ml formulation which we believe will offer patients and their physicians flexibility in choosing a dosing regimen that works best for them.”