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news.Daiichi Sankyo's investigational once-daily oral, direct factor Xa inhibitor, Edoxaban, is said to have been demonstrated superiority over Enoxaparin in preventing venous thromboembolic (VTE) events in patients following total knee replacement (TKR), in Phase III STARS E-3 (Studying Thrombosis After Replacement Surgery) study.
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Daiichi Sankyo has presented results of the study at the 21st International Congress on Thrombosis (ICT) in Milan, Italy.
Daiichi Sankyo’s Phase III STARS E-3 study, in Japan and Taiwan, is a multicenter, double-blind, double dummy and centrally randomised trial.
Daiichi Sankyo said that the primary end point of the study was the incidence of symptomatic pulmonary embolism (PE) and symptomatic and asymptomatic deep vein thrombosis (DVT). The primary safety endpoint was the incidence of major bleeding and clinically relevant non-major bleeding.
Takeshi Fuji, head of orthopedic surgery at Osaka Koseinenkin Hospital, said: “The combination of efficacy, tolerability and convenient once-daily oral dosing in this clinical setting further supports the role of Edoxaban in helping patients and physicians avoiding thrombotic events.
“These results are encouraging as they demonstrate efficacy of once-daily Edoxaban compared with twice daily subcutaneous enoxaparin.”
Daiichi Sankyo has submitted a new drug application to the Ministry of Health, Labor and Welfare in Japan, in March 2010, seeking approval of Edoxaban for the prevention of VTE after major orthopedic surgery.