Astellas is seeking an approval for the indication of the prevention of venous thromboembolism (VTE) in patients at risk, such as those undertaking orthopedic surgical procedures in the lower limbs.
Darexaban, an oral Factor Xa inhibitor discovered and developed by Astellas, directly and selectively inhibits activated Factor X in the cascade of blood coagulation and, thus, is expected to prevent VTE by suppressing the thrombin production.
The two Phase-II/III studies, which enrolled patients after having elective total knee or hip replacement surgeries in Japan and other Asian countries proved superior efficacy of Darexaban over placebo in VTE prevention.
Astellas said that YM150 is currently under development for indications of prevention of VTE, stroke prevention in atrial fibrillation (AF) patients and the prevention of ischemic vascular events in subjects with recent acute coronary syndromes (ACS).
The North American Phase-II study for VTE prevention in patients after elective primary knee arthroplasty demonstrated dose dependent efficacy of Darexaban in VTE prevention.
The international Phase-IIa study, which was conducted in Japan and other Asian countries, identified optimal dose range for further development of Darexaban for stroke prevention in AF patients.
Astellas expects to provide an additional therapeutic option, and further contribute to VTE prevention by introducing Darexaban with a new mechanism of action, into the Japanese market.