The European Medicines Agency is recommending that edoxaban (Lixiana) be made available for the prevention of stroke and systemic embolism in atrial fibrillation (AF) and the prevention and treatment of venous thromboembolism (VTE).
The move follows a positive review of the new oral anticoagulant by its Committee for Medicinal Products for Human use (CHMP). The recommendation, announced on 23 April 2015, now goes to the European Commission for approval.
Edoxaban, an antithrombotic agent, is a highly selective, direct and reversible inhibitor of factor Xa. It reduces thrombin generation, prolongs clotting time and reduces the risk of thrombus formation.
The CHMP says the product has the potential to reduce the combined risk of stroke and systemic embolic events in patients with nonvalvular AF who are at risk of stroke and systemic embolic events. It is also able to treat and reduce the risk of recurrence of symptomatic venous thromboembolism (VTE) in patients who have had acute symptomatic deep vein thrombosis or pulmonary embolism.
England’s National Institute for Health and Care Excellence (NICE) is due to publish draft guidance on the use of edoxaban for the treatment and secondary prevention of VTE towards the end of June 2015, with final guidance expected in October 2015.
A NICE appraisal committee is also due to meet on 30 June 2015 to formulate draft guidance for its use for stroke prevention in AF, according to a NICE spokesperson.
The product is manufactured by the Daiichi Sankyo Company, based in Tokyo, Japan.
