Daiichi Sankyo initiates Phase III trial of edoxaban in reducing recurrent VTE complications

Daiichi Sankyo Company, Limited (TSE: 4568), announced today that it has initiated a new large-scale pivotal Phase III trial for edoxaban, its investigational oral Factor Xa inhibitor. This new study, called HOKUSAI (pronounced hoe·koo·sigh) VTE, is evaluating the safety and efficacy of edoxaban in reducing recurrent venous thromboembolic (VTE) complications in patients with deep vein thrombosis (DVT) and/or pulmonary embolism (PE).

It is estimated that more than 900,000 fatal and non-fatal VTE events occur in the U.S. annually, and approximately 300,000 deaths are related to VTE per year.  In Europe, VTE affects more than 750,000 people in six major European countries (France, Germany, Italy, Spain, Sweden, UK) annually, and approximately 370,000 deaths are related to VTE per year in these countries.

"The incidence of VTE is predicted to double by 2050," said Harry R. Buller, M.D., Professor of Internal Medicine, chairman of the Department for Vascular Medicine at the Academic Medical Center, Amsterdam and chairman of the Steering Committee for HOKUSAI VTE.  "Based on what we've seen in Phase II and other trials, edoxaban shows promise as an agent to help fulfill the need for treatment options that are safe, effective and more convenient than the current standard of care, which requires extensive monitoring, careful dose adjusting and may have the potential for various drug and food interactions."

The primary efficacy endpoint for HOKUSAI VTE is the recurrence of symptomatic VTE (i.e., the composite of DVT, non-fatal PE and fatal PE). The primary safety assessment of the trial is the incidence of major and clinically relevant non-major bleeding.

"HOKUSAI VTE is the largest, single Phase III study ever undertaken in the area of VTE, and is our second large-scale edoxaban trial," said Glenn Gormley, president of Daiichi Sankyo Pharma Development. "Daiichi Sankyo is proud to be advancing the research of Factor Xa inhibitors with edoxaban, which may help prevent deadly clots in various patient populations."