Daiichi Sankyo Company, Limited announced that it has submitted a New Drug Application to the Ministry of Health, Labor and Welfare in Japan seeking approval of the anticoagulant, edoxaban, for the prevention of venous thromboembolism (VTE) after major orthopedic 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 3 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 orthopedic 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.
Date: April 6, 2010
Source: Daiichi Sankyo Company, Limited
Filed Under: Drug Discovery