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Developed solely by Daiichi Sankyo, edoxaban is an once-daily, oral anticoagulant that specifically, reversibly and directly inhibits factor Xa, which is an important factor in the coagulation system that leads to blood clotting. In 2011, we launched edoxaban as Lixiana® in Japan for the prevention of venous thromboembolism (VTE) in patients undergoing total knee replacement surgery, total hip replacement surgery, and hip fracture surgery.
Based on the two global phase 3 studies, ENGAGE AF-TIMI 48 for the prevention of stroke or systematic embolic events in patients with atrial fibrillation (irregular heart rate) and Hokusai-VTE for the treatment and prevention of recurrences of VTE in patients with an acute symptomatic deep vein thrombosis (DVT) and/or pulmonary embolism (PE), edoxaban is now approved and launched for those indications in more than 20 countries worldwide.
Daiichi Sankyo is committed to expanding scientific knowledge about edoxaban, as demonstrated through our research programs evaluating its use in a broad range of cardiovascular conditions, patient types and clinical settings in atrial fibrillation (AF) and venous thromboembolism (VTE) designed to further build on the results of the pivotal ENGAGE-AF and Hokusai-VTE studies. More than 100,000 patients worldwide are expected to participate in the edoxaban clinical research program, EDOSURE, which is comprised of more than 10 RCTs (randomized, controlled trials), non-interventional studies and registries, including completed, ongoing and future research.
Daiichi Sankyo discovered prasugrel, an oral antiplatelet agent that prevents blood clots, with our Japanese research partner, Ube Industries, and developed it globally in collaboration with Eli Lilly and Company. In 2009, we launched it as Effient® in the United States and as Efient® in Europe to prevent atherothrombotic events in patients with acute coronary syndrome undergoing percutaneous coronary intervention (PCI). To date, prasugrel has been approved in more than 70 countries around the world.
In Japan, prasugrel was developed in collaboration with Ube Industries. We launched Efient® for the treatment of patients with ischemic heart disease undergoing PCI in May 2014. Phase 3 studies on patients with ischemic cerebrovascular disease were completed in 2016, and Daiichi Sankyo is evaluating the data with regard to the next step.