Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) is moving towards marketing double-dose Copaxone in Europe. The company has reported receiving a positive outcome in the decentralized procedure for its new, three-times-a-week Copaxone 40 mg/ml formulation for the treatment of adults with relapsing forms of multiple sclerosis (RMS).
Teva said that the outcome follows a Positive Assessment Report from the UK, the Reference Member State’s Medicines and Healthcare Products Regulatory Agency (MHRA), and all Concerned Member States (CMS) in Europe who were involved in the procedure. Teva expects that granting of national authorizations will happen in the near future.
The three-times-a-week Copaxone 40 mg/ml formulation allows for an improved, less-frequent, subcutaneous dosing regimen for adults with RMS. The new formulation reduces the total number of injections by almost 60 percent, while maintaining the known benefits of once daily Copaxone 20 mg/ml.
Teva Global Specialty Medicines president and CEO Dr. Rob Koremans said, “We welcome the opportunity to make Copaxone 40 mg/ml available to patients with RMS in Europe. Three-times-a-week Copaxone 40 mg/ml will be available in Europe as early as the first quarter of 2015 with expected launches in Germany, Netherlands and Denmark. Launches in other EU countries are expected throughout 2015.”
Three-times-a-week Copaxone 40 mg/ml was approved by the US Food and Drug Administration (FDA) in January, 2014 and, since launch, has been prescribed to more than 40,000 patients.
Published by Globes [online], Israel business news - www.globes-online.com - on December 7, 2014
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