Daiichi Sankyo initiates Hokusai-VTE Cancer study of edoxaban for treatment of VTE associated with cancer.

Daiichi Sankyo Company, Limited announced the initiation of Hokusai-VTE Cancer, a multinational study which will investigate the efficacy and safety of edoxaban, an oral, once-daily selective factor Xa inhibitor, versus dalteparin for the treatment of VTE associated with cancer (other than basal-cell or squamous-cell carcinoma of the skin) for whom long-term treatment with a low molecular weight heparin (LMWH) is intended. The purpose of the study is to evaluate edoxaban in comparison with dalteparin in preventing the combined outcome of VTE recurrence or major bleeding following an acute deep vein thrombosis (DVT) or pulmonary embolism (PE) event in patients with cancer. The recruitment has started, and approximately 1,000 patients are expected to be enrolled in the study at clinical sites across 13 countries.

Edoxaban is currently marketed in Japan, the U.S., and Switzerland, and has also been recommended for approval in the EU by the European Committee for Medicinal Products for Human Use (CHMP). In other countries, regulatory review is ongoing.