SYS-CON MEDIA Authors: PagerDuty Blog, Michael Jannery, Pat Romanski, Elizabeth White, Liz McMillan

News Feed Item

Daiichi Sankyo Submits Edoxaban Marketing Authorization Application to the EMA for Once-Daily Use for Stroke Prevention in Atrial Fibrillation and for the Treatment and Prevention of Recurrence of Venous Thromboembolism

- 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

TOKYO and MUNICH, Jan. 7, 2014 /PRNewswire/ -- Daiichi Sankyo, Company Limited (hereafter, Daiichi Sankyo) today announced that the Marketing Authorization Application (MAA) for its investigational, oral, once-daily direct factor Xa-inhibitor edoxaban has been submitted to the European Medicines Agency (EMA). In Europe, Daiichi Sankyo is seeking approval for edoxaban for the prevention of stroke and systemic embolic events (SEE) in patients with non-valvular atrial fibrillation (NVAF), as well as for the treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE) and prevention of recurrence of symptomatic venous thromboembolism (VTE). If approved, edoxaban will be authorized for marketing in all European member states.

The MAA 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 atrial fibrillation (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 MAA in Europe for edoxaban represents our long standing commitment to addressing the needs of patients living with cardiovascular diseases, including AF or VTE," 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. "This milestone brings us one step closer to providing a new treatment option to patients living with AF or VTE, and we look forward to working with the EMA as it conducts its review of edoxaban."

Edoxaban is currently under regulatory review with the Japanese Ministry of Health, Labour and Welfare for NVAF and symptomatic VTE treatment.

About Edoxaban
Edoxaban is an investigational, oral, once-daily anticoagulant that specifically inhibits factor Xa, which is an important factor in the coagulation system that leads to blood clotting.3 The global edoxaban clinical trial program includes two phase 3 clinical studies, Hokusai-VTE and ENGAGE AF-TIMI 48 (Effective aNticoaGulation with Factor XA Next GEneration in Atrial Fibrillation). The results from these trials form the basis of the MAA for edoxaban for the prevention of stroke and SEE in patients with NVAF, as well as for the treatment of DVT or PE and prevention of recurrence of symptomatic VTE. 

Edoxaban is currently approved only in Japan, since April 2011, for the prevention of VTE after major orthopaedic surgery, and was launched in July 2011 under the brand name LIXIANA®. Elsewhere, including Europe and the U.S., edoxaban is currently in phase 3 clinical development and has not been approved in any indication.4

About Daiichi Sankyo 
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: www.daiichisankyo.com.

Contact
Michaela Paudler-Debus, PhD
Daiichi Sankyo Europe
[email protected]
+49-89-7808-685 (office)
+49-176-11780966 (mobile)

Forward-looking statements
This 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. 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 assume no responsibility for the updating of such forward-looking statements about future developments of the sector, legal and business conditions and the company.

References

  1. Giugliano, R et al. Edoxaban versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med 2013;369:2093-2104.
  2. Buller, 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: January 2014].

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Want to enable self-service provisioning of application environments in minutes that mirror production? Can you automatically provide rich data with code-level detail back to the developers when issues occur in production? In his session at DevOps Summit, David Tesar, Microsoft Technical Evangelist on Microsoft Azure and DevOps, will discuss how to accomplish this and more utilizing technologies such as Microsoft Azure, Visual Studio online, and Application Insights in this demo-heavy session.
Entuity®, a provider of enterprise-class network management solutions, today announced that it solidifies its position as a market leader through global enterprise customer acquisitions and a refined channel strategy. In 2014, Entuity increased new license revenues in EMEA by over 75 percent, and LATAM by over 125 percent as customers embraced Entuity for its highly automated solution and unified architecture. Entuity’s refined channel strategy focuses on even deeper strategic alignment with ke...
We are all here because we are sold on the transformative promise of The Cloud. But what good is all of this ephemeral, on-demand infrastructure if your usage doesn't actually improve the agility and speed of your business? How must Operations adapt in order to avoid stifling your Cloud initiative? In his session at DevOps Summit, Damon Edwards, co-founder and managing partner of the DTO Solutions, will highlight the successful organizational, process, and tooling patterns of high-performing c...
The 4th International DevOps Summit, co-located with16th International Cloud Expo – being held June 9-11, 2015, at the Javits Center in New York City, NY – announces that its Call for Papers is now open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the world's large...
Cloud Expo 2014 TV commercials will feature @ThingsExpo, which was launched in June, 2014 at New York City's Javits Center as the largest 'Internet of Things' event in the world.
“We help people build clusters, in the classical sense of the cluster. We help people put a full stack on top of every single one of those machines. We do the full bare metal install," explained Greg Bruno, Vice President of Engineering and co-founder of StackIQ, in this SYS-CON.tv interview at 15th Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
"People are a lot more knowledgeable about APIs now. There are two types of people who work with APIs - IT people who want to use APIs for something internal and the product managers who want to do something outside APIs for people to connect to them," explained Roberto Medrano, Executive Vice President at SOA Software, in this SYS-CON.tv interview at Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
In this demo at 15th Cloud Expo, John Meza, Product Engineer at Esri, showed how Esri products hook into Hadoop cluster to allow you to do spatial analysis on the spatial data within your cluster, and he demonstrated rendering from a data center with ArcGIS Pro, a new product that has a brand new rendering engine.
"Blue Box has been around for 10-11 years, and last year we launched Blue Box Cloud. We like the term 'Private Cloud as a Service' because we think that embodies what we are launching as a product - it's a managed hosted private cloud," explained Giles Frith, Vice President of Customer Operations at Blue Box, in this SYS-CON.tv interview at DevOps Summit, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
The Software Defined Data Center (SDDC), which enables organizations to seamlessly run in a hybrid cloud model (public + private cloud), is here to stay. IDC estimates that the software-defined networking market will be valued at $3.7 billion by 2016. Security is a key component and benefit of the SDDC, and offers an opportunity to build security 'from the ground up' and weave it into the environment from day one. In his session at 16th Cloud Expo, Reuven Harrison, CTO and Co-Founder of Tufin,...
CloudBees, Inc., has announced a $23.5 million financing round, led by longtime CloudBees investor Lightspeed Venture Partners. Existing investors Matrix Partners, Verizon Ventures and Blue Cloud Ventures also participated in the round. The latest funding announcement follows earlier rounds of $4 million, $10.5 million and $10.8 million, bringing the total investment in CloudBees to just under $50 million since the company’s inception in 2010. Previous venture investment rounds were led by Ma...
“We are strong believers in the DevOps movement and our staff has been doing DevOps for large enterprise environments for a number of years. The solution that we build is intended to allow DevOps teams to do security at the speed of DevOps," explained Justin Lundy, Founder & CTO of Evident.io, in this SYS-CON.tv interview at DevOps Summit, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
SYS-CON Media announced that Splunk, a provider of the leading software platform for real-time Operational Intelligence, has launched an ad campaign on Big Data Journal. Splunk software and cloud services enable organizations to search, monitor, analyze and visualize machine-generated big data coming from websites, applications, servers, networks, sensors and mobile devices. The ads focus on delivering ROI - how improved uptime delivered $6M in annual ROI, improving customer operations by minin...
The move in recent years to cloud computing services and architectures has added significant pace to the application development and deployment environment. When enterprise IT can spin up large computing instances in just minutes, developers can also design and deploy in small time frames that were unimaginable a few years ago. The consequent move toward lean, agile, and fast development leads to the need for the development and operations sides to work very closely together. Thus, DevOps become...
Puppet Labs on Wednesday released the DevOps Salary Report, based on salary data gathered from Puppet Labs' industry-recognized State of DevOps Report. The data confirms that market demand for DevOps skills is growing, and that DevOps engineers are among the highest paid IT practitioners today. That's because IT organizations today are grappling with how to be more agile and responsive to the business, while maintaining the stability of their infrastructure. DevOps practices, such as continuous ...