Daiichi Sankyo blood thinner drug reaches phase 3 goal

Daiichi Sankyo's blood clot and stroke prevention drug, edoxaban, has met its primary efficacy endpoint in a phase three clinical trial.

The clinical trial, ENGAGE, was evaluating the investigational, oral, once-daily direct factor Xa-inhibitor edoxaban against warfarin for the prevention of stroke or systemic embolic events (SEE) in patients with non-valvular atrial fibrillation (NVAF) and was found to achieve non-inferior efficacy. Once-daily edoxaban also demonstrated significant reductions in major bleeding compared to warfarin, achieving superiority for the principal safety endpoint.

"The results from the ENGAGE AF-TIMI 48 trial showed that edoxaban may provide a new treatment option for the prevention of stroke or systemic embolic events that demonstrates comparable efficacy to warfarin, while significantly reducing the risk of major bleeding. In addition, we identified an appropriate dose regimen for patients with clinical factors such as renal impairment and low body weight. In conducting this landmark trial we sought to provide clinicians with robust data, evident by the trial size and follow-up, high percentage of time in therapeutic range for the warfarin treatment arm, and very low rate of missing data. In addition, we specifically designed a comprehensive transition plan to protect patients from the undue risk of stroke and bleeding when switching to open-label anticoagulation at the end of the trial."

Robert Giugliano, MD, SM, FAHA, FACC, Senior Investigator with the TIMI Study Group, Physician Cardiovascular Medicine, Brigham and Women's Hospital, Associate Professor of Medicine, Harvard Medical School, and Co-Global Lead Investigator of the ENGAGE AF-TIMI 48 trial.

"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 US, Japan and Europe."

Glenn Gormley, MD, PhD, Global Head of Research and Development and Senior Executive Officer, Daiichi Sankyo Company, Ltd. and Executive Chairman of Daiichi Sankyo, Inc. in the United States (US).

Edoxaban is currently approved only in Japan, since April 2011, for the prevention of VTE after major orthopedic surgery, and was launched in July 2011 under the brand name Lixiana®. Elsewhere, including Europe and the US, edoxaban is currently in phase 3 clinical development and has not been approved in any indication.