Astellas drops development of blood thinner darexaban

Japanese drug major Astellas Pharma (TYO: 4503) says it has decided to discontinue the global development of darexaban maleate (development code name: YM150), an oral direct Factor Xa inhibitor for all indications.

The news is not a surprise, given that the drug was associated with a two to four-fold increase in bleeding when added to dual antiplatelet therapy in patients following an acute coronary syndrome. Also, Astellas earlier this year withdrew its marketing application in Japan after regulators called for additional studies (The Pharma Letter September 1).

Astellas had been developing darexaban globally for the indications of preventing venous thromboembolism after major orthopedic surgery, stroke prevention in atrial fibrillation and ischemic events prevention in acute coronary syndrome. The company said it had been considering the appointment of a partner for the Phase III clinical development and commercialization of darexaban for these indications rather than developing and commercializing it alone.