Daiichi Sankyo’s once-daily bloodthinner Lixiana has been approved for use across the European Union for stroke prophylaxis and to prevent and treat certain blood clots.

The European Commission has green-lighted the drug’s use to prevent stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation with one or more risk factors, such as congestive heart failure or hypertension, as well as to treat and prevent deep vein thrombosis (DVT) and pulmonary embolism (PE).

Lixiana (edoxaban) is a once-daily selective factor Xa-inhibitor which, in clinical trials, was shown to have comparable efficacy to veteran anticoagulant warfarin but with a superior safety profile, significantly reducing the risk of major bleeds (2.75% versus 3.43% per year, respectively, in the stroke prevention cohort).

Atrial fibrillation affects over six million people in Europe, who are at a five-fold increased risk of stroke compared to the general population, with an estimated financial burden of over 38 billion euros a year. VTE also represents a major cause of morbidity and mortality, resulting in over 500,000 deaths in region each year, the firm noted.

“AF-related stroke as well as DVT and PE create a significant societal and economic health burden. We welcome the EC approval of Lixiana, which means physicians and patients may benefit from a new treatment option to effectively manage these debilitating and life-threatening conditions,” said Jan van Ruymbeke, Daiichi Sankyo Europe’s chief executive.

The drug is already marketed in the US, Japan and Switzerland, and regulatory reviews in other countries are ongoing.