Three Times a Week Copaxone has positive decision from MHRA and now EU decentralised approval for Multiple Sclerosis- Teva
Teva Pharmaceutical Industries Ltd.,announced that it has received a positive outcome in the decentralized procedure for its new, Three-Times-a-Week Copaxone (glatiram acetate) 40 mg/ml formulation for the treatment of adults with relapsing forms of Multiple Sclerosis (RMS). The outcome follows 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 who were involved in the procedure.
The three-times-a-week Copaxone 40 mg/ml formulation will allow 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.