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Daiichi Sankyo discovered prasugrel with our Japanese research partner, Ube Industries and developed it in collaboration with Eli Lilly and Company. Prasugrel is an oral antiplatelet agent that prevents blood clots. In 2009, we launched it as Effient® in the United States and as Efient® in Europe to prevent atherothrombotic events (causing inflammation of the arteries) 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, we launched Efient® for the treatment of patients with ischemic heart disease undergoing PCI in May 2014, and are currently conducting a phase 3 study on patients with ischemic cerebrovascular disease (when a blood vessel becomes blocked).
Developed solely by Daiichi Sankyo, edoxaban is an oral, once-daily 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 to prevent venous thromboembolism (VTE) in patients undergoing total knee replacement surgery, total hip replacement surgery, and hip fracture surgery. It was the first available factor Xa inhibitor in that country.
Two global phase 3 studies, ENGAGE AF-TIMI 48 for the prevention of stroke or systemic 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), have been completed and Daiichi Sankyo is aiming to receive approval for those indications in FY2014.
We've been working on denosumab since 2007, when we licensed the rights from Amgen to manufacture and market this antibody in Japan. Denosumab was developed to treat and prevent various bone disorders including osteoporosis and bone metastases (the spread of cancer to the bones). It is the world's first human monoclonal antibody to target RANK ligand, a protein that plays a key role in bone breakdown.
In Japan, Daiichi Sankyo received approval to manufacture and market Denosumab as RANMARK® for the treatment of bone complications stemming from multiple myeloma and bone metastases from solid tumors in January 2012, and approval for the treatment of osteoporosis in March 2013.
We're currently participating in the global phase III study of adjuvant treatment for women with early-stage breast cancer, and we're conducting phase II studies on Japanese patients with rheumatoid arthritis and giant cell tumor of the bone.