30 July 2014 | Regulatory | By BioSpectrum Bureau
Singapore: Bristol-Myers Squibb and Pfizer have recieved European Commission approval for Eliquis for the treatment of DVT and Pulmonary Embolism (PE), and the prevention of recurrent deep vein thrombosis (DVT) and PE in adults.
In the trial, Eliquis was shown to be non-inferior for the treatment of recurrent venous thromboembolism (VTE)/VTE-related death and was statistically superior in the primary safety endpoint of major bleeding vs. enoxaparin/warfarin
According to the report, Eliquis demonstrated a superior reduction in VTE/all-cause death with no statistical difference in major bleeding events vs placebo
European Commission approval applies to all European Union (EU) member states as well as Iceland and Norway.