EU Advisory Committee Recommends Daiichi Sankyo’s Anticoagulant
Daiichi Sankyo Company reports that the European Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Lixiana (edoxaban), an oral, once-daily selective factor Xa inhibitor, for the prevention of stroke and systemic embolism (SE) in adult patients with non-valvular atrial fibrillation (NVAF) with one or more risk factors. The CHMP also recommended approval of Lixiana for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. The two related conditions DVT and PE are collectively referred to as venous thromboembolism (VTE).
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 III clinical studies, Hokusai-VTE and ENGAGE AF-TIMI 48, 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 and SE in NVAF, respectively. Edoxaban is currently marketed in Japan and the US and has received approval in Switzerland and regulatory review is ongoing in other countries.
Source: Daicchi Sankyo