Daiichi Sankyo Company has launched a new formulation of Lixiana 60 mg tablets (JAN: Edoxaban Tosilate Hydrate, INN: edoxaban, approval to market) in Japan for the recently approved indications: the prevention of ischemic stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) and the treatment and recurrence prevention of venous thromboembolism (VTE) [deep vein thrombosis (DVT) and pulmonary thromboembolism (PE).
Lixiana was approved in Japan in April 2011, for the prevention of VTE after major orthopedic surgery and was launched in July 2011. Lixiana was also approved in Japan in September 2014 for the prevention of ischemic stroke and systemic embolism in patients with NVAF and for the treatment and recurrence prevention of VTE. Daiichi Sankyo has also filed for approval of once-daily edoxaban in both the US and EU for the reduction in risk of stroke in NVAF and for symptomatic VTE in patients with DVT and/or PE.
Atrial fibrillation (AF) is a condition in which the heartbeat is rapid and irregular, and can potentially lead to a stroke. AF is a common condition, affecting approximately 2.3-3.4 per cent of people in developed nations. AF affects approximately 6 million people in the EU, approximately 6.1 million people in the US. approximately 1.5 million people in Brazil and more than 800,000 people in Japan.10Stroke due to all causes is the second most common cause of death worldwide, responsible for approximately 6.2 million deaths each year. Compared to those without AF, people with the arrhythmia have a 3-5 times higher risk of stroke. Strokes due to AF are nearly twice as likely to be fatal than strokes in patients without AF at 30 days and have poorer prognosis than non-AF related strokes, with a 50 per cent increased risk of remaining disabled at three months.
VTE is an umbrella term for two conditions, DVT and PE. DVT is a blood clot found anywhere in the deep veins of the legs, while PE occurs when part of a clot detaches and lodges in the pulmonary arteries, causing a potentially fatal condition. VTE is a major cause of morbidity and mortality worldwide with an annual incidence estimated at one per 1,000 (with some age and regional variation). In Japan, there is an estimated annual incidence of 0.19 per cent for DVT and 0.05 per cent for PE. In the EU, it is estimated that 430,000 PE events, 680,000 DVT events and 540,000 deaths occur each year. In the US, it is estimated that more than 950,000 VTE events and approximately 300,000 VTE related deaths occur each year.
Edoxaban is an investigational, oral, once-daily anticoagulant that specifically inhibits factor Xa, which is an important factor in the coagulation system that leads to blood clotting. The global edoxaban clinical trial program includes two phase 3 clinical studies, Hokusai-VTE and ENGAGE AF-TIMI 48 (Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation), which included nearly 30,000 patients combined. The results from these trials form the basis of regulatory filings for edoxaban for symptomatic VTE in patients with DVT and/or PE, and for the prevention of stroke in NVAF, respectively. Edoxaban is currently under regulatory review in the US and the EU for these indications.