Positive Ph III results for Daiichi Sankyo's edoxaban in VTE

Japanese drug major Daiichi Sankyo (TYO: 4568) has released encouraging results from the global Phase III Hokusai-VTE study of edoxaban (trade name Lixiana) in 8,292 patients with either acute symptomatic deep vein thrombosis (DVT), pulmonary embolism (PE), or both, suggesting it could compete with rivals such as Bayer, Boehringer Ingelheim, Johnson & Johnson, Bristol-Myers and Pfizer in the venous thromboembolism market, which has been forecast as reaching a value of more than $10 billion.

The study found that the investigational, oral, once-daily direct factor Xa-inhibitor edoxaban met the primary efficacy endpoint of non-inferiority compared to warfarin, following initial use of heparin in both arms, for the treatment and prevention of recurrent symptomatic venous thromboembolism (VTE). Once-daily edoxaban also demonstrated superiority compared to warfarin for the principal safety outcome of clinically relevant bleeding (the composite of major or clinically relevant non-major bleeding).

Results from Hokusai-VTE were presented over the weekend at the European Society of Cardiology (ESC) Congress 2013 in Amsterdam and published online in the New England Journal of Medicine.