Firm says decision results from difficulties finding a partner to conduct Phase III trials.
Astellas Pharma is discontinuing global development of its oral direct factor Xa inhibitor darexaban maleate (YM150), ostensibly because it can’t find a Phase III development partner. Darexaban had been in development of preventing venous thromboembolism (VTE) after major orthopaedic surgery, stroke prevention in atrial fibrillation, and preventing ischemic events in acute coronary syndrome.
However, in August the firm presented data from a Phase II, 1,279-patient study which suggested that darexaban therapy increased bleeding two- to four-fold in patients with acute coronary syndrome. And back in February Astellas withdrew its previously filed submission for approval of darexaban in Japan for use in preventing the risk of venous thromboembolism, because the country’s regulator said additional clinical studies would be needed. At that time the firm said it was considering appointing a partner for development and commercialization of darexaban in the U.S. and Europe for the VTE prevention indication, and for global development of the drug in preventing stroke and atrial fibrillation.
It says the decision to ditch further development of the drug globally was made due to a number of factors, including difficulty in finding a suitable partner, increasing competition from similar drug classes, and prioritization of its pipeline.