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ARTICLE | Company News

Daiichi submits edoxaban NDA

January 9, 2014 2:08 AM UTC

Daiichi Sankyo Co. Ltd. (Tokyo:4568) submitted an NDA to FDA for Savaysa edoxaban, an oral Factor Xa inhibitor. The pharma is seeking approval of the product to prevent stroke and systemic embolic events in patients with non-valvular atrial fibrillation (AF); to treat deep vein thrombosis (DVT) or pulmonary embolism (PE); and to prevent recurrence of symptomatic venous thromboembolism (VTE). On Tuesday, Daiichi submitted an MAA to EMA for edoxaban for the indications. ...