Astellas abandons oral anticoagulant darexaban
pharmafile | September 30, 2011 | News story | Research and Development | Astellas, Eliquis, Xarelto, darexaban
Astellas Pharma has abandoned the development of its oral direct factor Xa inhibitor darexaban.
The Japanese firm blamed both the difficulty of finding a suitable development partner for the anticoagulant and – perhaps even more pertinently – the increasing competition in this class.
In recent times existing direct factor Xa inhibitors such as Bayer’s Xarelto (rivaroxaban) and Bristol-Myers Squibb/Pfizer’s Eliquis (apixaban) have made great strides in clinical trials.
They both fared better than the standard of care warfarin when it comes to reducing the risk of stroke in atrial fibrillation (AF) patients, according to research this year.
Astellas had hoped darexaban might be indicated for preventing venous thromboembolism (VTE) after major orthopedic surgery, as well as stroke prevention in AF patients and stopping ischaemic events in acute coronary syndrome.
A year ago the company submitted a market authorisation application for the drug, to prevent VTE, to Japanese authorities.
Two Phase II/III studies of patients who had elective total knee or hip replacements in Japan and other Asian countries found darexaban superior to placebo in this indication.
A North American Phase II study for VTE prevention following elective primary knee arthroplasty demonstrated dose dependent efficacy of darexaban, while an international Phase IIa study identified optimal doses for stroke prevention in AF patients.
However, the manufacturer clearly feels now that these results were not enough to warrant spending further time and money.
Annoucing its decision to shelve the drug, Astellas said it “had been considering the appointment of a partner for the Phase III clinical development and commercialisation of darexaban for these indications rather than developing and commercialising it alone”.
But, the statement added, “finding a suitable partner has been difficult and considering intensified competition for this product and the order of priority in its pipeline, Astellas has decided to discontinue development of darexaban for all indications”.
The move will not have an effect on the financial forecast for Astellas’ current fiscal year ending 31 March 2012, the company adds.
Adam Hill
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