New drug application for edoxaban submitted in Japan

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Daiichi Sankyo is seeking approval in Japan for edoxaban in new indications for non-valvular atrial fibrillation and symptomatic venous thromboembolism.

Daiichi Sankyo has announced that it has submitted a supplemental new drug application for its oral, once-daily direct factor Xa-inhibitor edoxaban (Lixiana) for review by the Japanese Ministry of Health, Labour and Welfare. Daiichi Sankyo is seeking approval in Japan for edoxaban in new indications for non-valvular atrial fibrillation and symptomatic venous thromboembolism.

 

The submission is based on data from an extensive global clinical trial programme that compared treatment with once-daily edoxaban to warfarin, a current standard of care for patients with atrial fibrillation or venous thromboembolism. The two clinical trials that formed the basis of the submission, ENGAGE AF-TIMI 48 and Hokusai-VTE, are the largest comparative trials of a novel oral anticoagulant in these patient populations, involving 21,105 and 8,292 patients, respectively.


“The submission of our supplemental new drug application in Japan for edoxaban represents our long standing commitment to addressing the needs of patients living with cardiovascular diseases, including those living with atrial fibrillation or venous thromboembolism,” said Glenn Gormley, senior executive officer and global head of Research and Development, Daiichi Sankyo and president and CEO of Daiichi Sankyo in the United States. “We look forward to working with the Japanese Ministry of Health, Labour and Welfare throughout its review of these new indications for edoxaban. Additionally, we plan to submit applications for edoxaban in the USA and Europe by the first quarter of 2014.”

 

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