Daiichi Sankyo submits supplemental New Drug Application in Japan for LIXIANA® (Edoxaban Tosilate Hydrate) for new indications

• Submission based on the two largest comparative phase 3 clinical trials of a novel oral anticoagulant in patients with non-valvular atrial fibrillation or symptomatic venous thromboembolism
• Regulatory filings for once-daily edoxaban planned by Q1 2014 in the U.S. and Europe

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that it has submitted a supplemental New Drug Application (NDA) for its oral, once-daily direct factor Xa-inhibitor LIXIANA® (Edoxaban Tosilate Hydrate) 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 (AF) and symptomatic venous thromboembolism (VTE).

The supplemental NDA 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. 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.^1,2

“The submission of our supplemental NDA 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, MD, PhD, Senior Executive Officer and Global Head of Research and Development, Daiichi Sankyo Co., Ltd. and President and CEO of Daiichi Sankyo, Inc. 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 U.S. and Europe by the first quarter of 2014.”

References

1. Giugliano, R et al. Edoxaban versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med 2013;369:2093-2104.
2. Büller, H et al. Edoxaban versus Warfarin for the treatment of Symptomatic Venous Thromboembolism. N Engl J Med 2013;369:1406-1415.
3. Ogata, K et al. Clinical Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Novel Factor Xa Inhibitor Edoxaban in Healthy Volunteers. J Clin Pharmacol 2010;50:743-753.
4. Daiichi Sankyo press release – Daiichi Sankyo Launches LIXIANA® (edoxaban), a Direct Oral Factor Xa Inhibitor, in Japan for the Prevention of Venous Thromboembolism after Major Orthopaedic Surgery. 19 July 2011. Available at: http://www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/005784.html. [Last accessed: December 2013].