Daiichi Sankyo Company, Limited has submitted a New Drug Application to the Ministry of Health, Labour and Welfare in Japan seeking approval of the anticoagulant, edoxaban, for the prevention of venous thromboembolism (VTE) after major orthopaedic surgery.

Edoxaban, being developed solely by Daiichi Sankyo, is an oral anticoagulant that directly and specifically inhibits Factor Xa, a clotting factor in the blood. Results from pivotal phase-III studies showed that once-daily oral administration of edoxaban reduced the incidence of VTE in patients undergoing total knee replacement or total hip replacement, and the non-inferiority to injectable enoxaparin sodium was confirmed.

“Upon approval, we believe that edoxaban, with its simple once-daily oral dosing, will be a significant improvement for patients undergoing orthopaedic surgery in Japan,” said Dr Kazunori Hirokawa, head of the R&D Division of Daiichi Sankyo, Co, Ltd. The pivotal phase-III studies conducted to support this first application in Japan – one in knee surgery and the other in hip surgery – were randomized, double-blind, parallel group, multi-center trials comparing a once-daily, 30 mg oral dose of edoxaban to 2,000 IU (20 mg) twice-daily subcutaneous injections of enoxaparin sodium. Treatment was provided for 11 to 14 days in both trials.

The primary efficacy endpoint in both trials was to confirm non-inferiority of edoxaban to enoxaparin sodium for the prevention of asymptomatic and symptomatic deep vein thrombosis and symptomatic pulmonary embolism. The primary safety endpoint in both trials was to compare the incidence of major and clinically relevant non-major bleeding between edoxaban and enoxaparin sodium groups. Full trial results will be submitted for presentation and publication in peer-reviewed settings.

The global clinical development program for edoxaban includes several indications, including the prevention of stroke and systemic embolic events in patients with atrial fibrillation, as well as the acute treatment and long-term secondary prevention of VTE. “Early phase data show that edoxaban is an innovative anticoagulant with direct, specific and reversible activity on Factor Xa, which is being investigated as a treatment for a variety of medical conditions, such as atrial fibrillation and VTE, as an alternative to current oral and injectable products,” said Dr Hirokawa.