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Trials & Filings

Daiichi Submits sNDA for Lixiana

Seeks Japanese approval for AF, VTE

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Daiichi Sankyo has submitted an sNDA to Japan’s Ministry of Health, Labour and Welfare for its oral, once-daily direct factor Xa-inhibitor, Lixiana (edoxaban tosilate hydrate). The company is seeking approval in new indications for non-valvular atrial fibrillation (AF) and symptomatic venous thromboembolism (VTE).

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

The company plans to submit applications for edoxaban in the U.S. and Europe by 1Q14.

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