Navigation Links
Daiichi Sankyo Launches LIXIANA® (edoxaban), a Direct Oral Factor Xa Inhibitor, in Japan for the Prevention of Venous Thromboembolism after Major Orthopedic Surgery

TOKYO, July 19, 2011 /PRNewswire/ -- Building on its cardiovascular portfolio, Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo), is proud to announce the launch of LIXIANA® (JAN: Edoxaban Tosilate Hydrate, INN: edoxaban) in Japan. This announcement follows the first marketing approval for edoxaban 15 mg and 30 mg tablets by the Japanese Ministry of Health, Labor and Welfare in April 2011 (1), and marks the first time edoxaban is commercially available to patients in any global market.

Edoxaban is a once-daily, oral anticoagulant that specifically, reversibly and directly inhibits the enzyme, Factor Xa, a clotting factor in the blood. Results from clinical studies supported the approval of edoxaban for the prevention of venous thromboembolism (VTE) in patients with total knee arthroplasty, total hip arthroplasty and hip fracture surgery.

"Today's launch of edoxaban marks the global debut of the medication, which is an exciting breakthrough for patients who require VTE prevention after major orthopedic surgery," said Joji Nakayama, president and CEO of Daiichi Sankyo. "Edoxaban demonstrates solid efficacy in clinical trials (2, 3) in this population of patients. Its predictable pharmacokinetic and pharmacodynamic profile allows for a convenient, once-daily dosing."

The global clinical development program for edoxaban is focused on several indications, including stroke prevention in atrial fibrillation (AF) patients, and treatment and prevention of recurrent VTE. Edoxaban is currently being assessed in the Phase III ENGAGE AF-TIMI 48 study (4), an ongoing, multinational, randomized, double-blind trial evaluating the efficacy and safety of edoxaban in preventing stroke and systemic embolic events in patients with AF. More than 21,000 patients with AF in 46 countries are being examined, making this the largest trial in this indication to date. In addition, Daiichi Sankyo is currently enrolling patients in its HOKUSAI VTE study (5) – the largest single, double-blind, randomized, multinational Phase III study for the treatment and prevention of recurrent VTE, involving approximately 7,500 patients in 450 clinical sites in approximately 40 countries worldwide.

About Venous ThromboembolismVenous thromboembolism (VTE) is the term for the generation of a blood clot and the obstruction of a vein or a pulmonary artery by a blood clot. Deep vein thrombosis (DVT) and pulmonary embolism (PE) are types of VTE. DVT is a blood clot anywhere in the deep veins of the legs or pelvis. PE is caused by such a clot that breaks off and then travels to the lungs, lodging in the pulmonary arteries.

About EdoxabanEdoxaban is a once-daily oral anticoagulant that directly inhibits Factor Xa, an important factor in the coagulation process. Edoxaban is currently available only in Japan, licensed for the prevention of venous thromboembolism (VTE) in patients undergoing total knee arthroplasty, total hip arthroplasty and hip fracture surgery (1). Daiichi Sankyo continues to develop edoxaban at a global level as a potential new treatment for stroke prevention in atrial fibrillation, and the treatment and prevention of recurrent VTE. Notably, Daiichi Sankyo has more than 25 years experience conducting research in the area of Factor Xa inhibition and was the first company to study these compounds in humans.

About Daiichi SankyoThe Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address the diversified, unmet medical needs of patients in both mature and emerging markets. While maintaining its portfolio of marketed pharmaceuticals for hypertension, hyperlipidemia, and bacterial infections, the Group is engaged in the development of treatments for thrombotic disorders and focused on the discovery of novel oncology and cardiovascular-metabolic therapies. Furthermore, the Daiichi Sankyo Group has created a "Hybrid Business Model," which will respond to market and customer diversity and optimize growth opportunities across the value chain. For more information, please visit


  2. T. Fuji et al., Edoxaban versus enoxaparin for thromboprophylaxis after total knee replacement: The STARS E-3 trial 21st International Congress of Thrombosis, July 6 – 9 2010, Milano.
  3. T. Fuji et al., Efficacy and Safety of Edoxaban Versus Enoxaparin for the Prevention of Venous Thromboembolism Following Total Hip Arthroplasty: STARS J-V trial, December 4-7 2010, Orlando, Florida.
  4. NCT00781391. Last accessed July 2011. Available at:
  5. NCT00986154. Last accessed: July 2011. Available at

For more information, please contact:Toshiaki Sai

Daiichi Sankyo, Co., Ltd. (Japan)

+81-3-6225-1126 (office)

Alyssa Dargento

Daiichi Sankyo, Inc. (US)

(973) 944-2913 (office)

(973) 727-1464 (mobile)Dr. Michaela Paudler-Debus

Daiichi Sankyo Europe GmbH

+49 (0)89-78 08 685 (office)

+49 (0)172-845 8974 (mobile)Forward-looking statementsThis press release contains forward-looking statements and information about future developments in the sector, and the legal and business conditions of DAIICHI SANKYO, Co. Ltd, DAIICHI SANKYO, Inc., and DAIICHI SANKYO EUROPE GmbH. Such forward-looking statements are uncertain and are subject at all times to the risks of change, particularly to the usual risks faced by a global pharmaceutical company, including the impact of the prices for products and raw materials, medication safety, changes in exchange rates, government regulations, employee relations, taxes, political instability and terrorism as well as the results of independent demands and governmental inquiries that affect the affairs of the company. All forward-looking statements contained in this release hold true as of the date of publication. They do not represent any guarantee of future performance. Actual events and developments could differ materially from the forward-looking statements that are explicitly expressed or implied in these statements. DAIICHI SANKYO, Co. Ltd, DAIICHI SANKYO, Inc., and DAIICHI SANKYO EUROPE GmbH assume no responsibility for the updating of such forward-looking statements about future developments of the sector, legal and business conditions and the company.


SOURCE Daiichi Sankyo
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Daiichi Sankyo and Forest Laboratories Finalize Contract for Co-Promotion of AZOR(TM)
2. FDA Grants Priority Review for Daiichi Sankyo, Lilly Drug, prasugrel
3. Daiichi Sankyo/Eli Lillys Effient and Astrazenecas Ticagrelor May Offer Advantages in the Treatment of Post-Myocardial Infarction
4. FDA Extends Review Period for Daiichi Sankyo, Lilly Investigative Antiplatelet Drug, Prasugrel
5. Daiichi Sankyo Announces Clinical Study Data for Oral Factor Xa Inhibitor DU-176b
6. Daiichi Sankyo and Lilly Respond to Speculation on Status of Prasugrel New Drug Application
7. Daiichi Sankyo Initiates Phase III Trial of Its Investigational Factor Xa Inhibitor, DU-176b, in Patients With Atrial Fibrillation
8. Daiichi Sankyo Initiates Largest Single, Double-Blind, Randomized, Phase III Trial for Treatment and Prevention of Recurrent Venous Thromboembolism
9. Daiichi Sankyo Co, Ltd. Joins the National Cherry Blossom Festival in Washington D.C. as Centennial Celebration Committee Co-Chair
10. Daiichi Sankyo/Lilly Respond to ACCF/AHA Clinical Alert on Antiplatelet Therapy
11. Accumetrics, Inc., Daiichi Sankyo, Inc. and Eli Lilly and Company Launch Strategic U.S. Collaboration
Post Your Comments:
(Date:6/24/2016)... , June 24, 2016  Consumers have taken ... regulators/payers have placed more emphasis on patient outcomes. ... support programs in the pharmaceutical industry have evolved ... Consequently, pharmaceutical companies are focusing on becoming more ... providing products and services that improve health. ...
(Date:6/24/2016)... June 24, 2016 ... announced the addition of the " Global Markets ... This report focuses ... an updated review, including its applications in various applications. ... market, which includes three main industries: pharmaceutical and biotechnology, ...
(Date:6/24/2016)... , June 24, 2016  American Respiratory Labs (ARL), a ... now able to perform sophisticated lung assessments in patients, homes, thanks ... Inc. Patients are no longer limited to having ... PRO ® , ARL patients like Jeanne R. of ... the comfort of her own home. ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... June 26, 2016 , ... Pixel Film Studios Released ProSlice Levels, a ... can give their videos a whole new perspective by using the title layers ... Film Studios. , ProSlice Levels contains over 30 Different presets to choose from. ...
(Date:6/25/2016)... ... ... Austin residents seeking Mohs surgery services, can now turn to Dr. Jessica ... Peckham for medical and surgical dermatology. , Dr. Dorsey brings specialization to include Mohs ... Mohs Micrographic Surgery completed by Dr. Dorsey was under the direction of Glenn Goldstein, ...
(Date:6/25/2016)... ... 25, 2016 , ... Dr. Calvin Johnson has dedicated his ... implemented orthobiologic procedures as a method for treating his patients. The procedure is ... to perform the treatment. Orthobiologics are substances that orthopaedic surgeons use to help ...
(Date:6/24/2016)... ... , ... June 19, 2016 is World Sickle Cell Observance Day. In an ... of holistic treatments, Serenity Recovery Center of Marne, Michigan, has issued a ... Cell Disease (SCD) is a disorder of the red blood cells, which can cause ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San ... Society and the Road To Recovery® program to drive cancer patients to and from ... adults to ensure the highest quality of life and ongoing independence. Getting to ...
Breaking Medicine News(10 mins):