Daiichi Sankyo's edoxaban shows comparable efficacy to warfarin in Phase III trial

Japanese drug major Daiichi Sankyo (TYO: 4568) says that its blood thinner edoxaban met the primary efficacy endpoint for stroke prevention compared to warfarin for patients with atrial fibrillation in a Phase III trial.

The Phase III ENGAGE AF-TIMI 48 study found that the investigational, oral, once-daily direct factor Xa-inhibitor edoxaban met the primary efficacy endpoint of non-inferiority compared to warfarin for the prevention of stroke or systemic embolic events (SEE) in patients with non-valvular atrial fibrillation (NVAF). Edoxaban also demonstrated significant reductions in major bleeding compared to warfarin, achieving superiority for the principal safety endpoint.

Glenn Gormley, global head of R&D and senior executive officer of Daiichi Sankyo and executive chairman of Daiichi Sankyo in the USA, said: “The edoxaban clinical trial program, the largest in the history of Daiichi Sankyo, has now yielded positive data for edoxaban in two major diseases, stroke prevention in atrial fibrillation and treatment of acute venous thromboembolism. Based on the findings from ENGAGE AF-TIMI 48 and Hokusai-VTE, we look forward to submitting New Drug Applications for edoxaban in both indications by the first quarter of 2014 in the USA, Japan and Europe.” The drug is already sold in Japan under the brand name Lixianal.