Navigation Links
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
Date:1/7/2014

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
'/>"/>

SOURCE Daiichi Sankyo
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Daiichi Sankyos Once-Daily Edoxaban Meets Primary Efficacy Endpoint for Stroke Prevention and Superiority for the Principal Safety Endpoint Compared to Warfarin for Patients with Atrial Fibrillation in a Phase 3 Clinical Trial
2. Daiichi Sankyos Once-Daily Edoxaban Shows Comparable Efficacy and Superiority for the Principal Safety Endpoint Compared to Warfarin in a Phase 3 Study for the Treatment of Symptomatic VTE and Prevention of its Recurrence
3. Daiichi Sankyo CEO John Gargiulo Elected as National Pharmaceutical Councils Chairman of the Board
4. Daiichi Sankyo ha completato larruolamento dei pazienti per lo studio Hokusai-VTE su Edoxaban, il piĆ¹ ampio trial clinico di fase 3 per il trattamento delle tromboembolie venose ricorrenti
5. Daiichi Sankyo Completes Enrolment in Hokusai - VTE, investigating once-daily Edoxaban in the Largest Single Phase 3 Study for the Treatment and Prevention of Recurrence of VTE
6. Daiichi Sankyo, Inc. Receives FDA Approval to Package Product at New Facility in Bethlehem, PA
7. Orexigen Resubmits Contrave New Drug Application
8. Soligenix Submits NIAID Contract Proposal for Development of a Thermostable Ricin Vaccine
9. Omeros Submits OMS302 Marketing Authorization Application to European Medicines Agency
10. Omeros Submits New Drug Application to U.S. FDA for OMS302
11. Oramed Submits Pre-IND Meeting Request to FDA for its Oral Exenatide Capsule ORMD-0901
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... LOUISVILLE, Ky. , Jan. 15, 2014  Manufacturers, ... technologies must be able to protect their most ... (Logo: http://photos.prnewswire.com/prnh/20130716/CL46586LOGO ) Because ... Industry, it steadfastly remains one of the most ...
(Date:1/15/2014)... 2014 MultiCell Technologies, Inc. (OTC Bulletin Board: ... application concerning composition of matter, biological targets, mechanism of ... death.  This patent application describes a ... molecules (VSRNAs) which interfere with the basic homeostatic cellular ...
(Date:1/15/2014)... TORONTO , Jan. 15, 2014  According to ... medical technology market intelligence, the United ... occlusion (TEO) device markets will expand moderately through ... fastest-growing segments. In particular, increasing interest in drug-eluting ...
Breaking Medicine Technology:Intellectual Property Insurance for Medical-related Products and Services 2MultiCell Technologies Files Patent Application Covering New Class of RNA Therapeutics 2MultiCell Technologies Files Patent Application Covering New Class of RNA Therapeutics 3US and European Transcatheter Embolization and Occlusion Device Market to Surpass $1.6 Billion by 2022 2US and European Transcatheter Embolization and Occlusion Device Market to Surpass $1.6 Billion by 2022 3
... Computerized tomographic (CT),colonography, also known as virtual colonoscopy, ... flexible tube with a camera to view the,lining ... detect cancer and,precancerous polyps and could serve as ... the results of the American College of,Radiology Imaging ...
... Department of,Justice announced today that it will not ... (CRC) to develop and publicize model contract language,for ... Department said,the language is not likely to be ... in contract negotiations, potentially reducing costs,and shortening the ...
Cached Medicine Technology:Video: Large, Multi-Center Trial Demonstrates Comparable Accuracy for Virtual Colonoscopy and Standard Colonoscopy 2Video: Large, Multi-Center Trial Demonstrates Comparable Accuracy for Virtual Colonoscopy and Standard Colonoscopy 3Video: Large, Multi-Center Trial Demonstrates Comparable Accuracy for Virtual Colonoscopy and Standard Colonoscopy 4Justice Department Will Not Oppose CEO Roundtable on Cancer's Proposal 2
(Date:4/18/2014)... one of your worst memories? How did it make ... during a negative personal experience, such as how sad ... to emotional distress, especially when you can,t stop thinking ... up, thinking about the context of the memories, rather ... effective way to alleviate the negative effects of these ...
(Date:4/18/2014)... lead to potential new treatments for breaking the cycle ... Fibrosis, or scarring, is a hallmark of the disease, ... lead to serious organ damage and, in some cases, ... on findings made by Swati Bhattacharyya, PhD, research assistant ... specific protein plays in promoting fibrosis. , "Our ...
(Date:4/17/2014)... of the most popular vaccine brands for children may ... be overlooking some cost factors when choosing vaccines, driving ... option, according to a new study by University of ... can be driven by numerous factors," says Sheldon H. ... of computer science and of mathematics at the U. ...
(Date:4/17/2014)... published in the April issue of Immunity , ... for Medical Research, says it,s time to take a ... treating sepsis, which kills millions worldwide every year, ... molecules released into the bloodstream to fight an injury ... necessary for maintaining good health without inflammation, wounds ...
(Date:4/17/2014)... as many as 10 million older Americans suffer from ... isolation. , However, new research a project that ... for six years found that Internet use among ... more than 30 percent. , "That,s a very strong ... of telecommunication, information studies and media who led the ...
Breaking Medicine News(10 mins):Health News:New study suggests a better way to deal with bad memories 2Health News:New study suggests a better way to deal with bad memories 3Health News:New clues on tissue scarring in scleroderma 2Health News:Study recalculates costs of combination vaccines 2Health News:Feinstein Institute researcher publishes new perspective on sepsis 2Health News:Internet use can help ward off depression among elderly 2
... Hepatitis ... C Relapsers and Nonresponders, KENILWORTH, N.J., Nov. 15 ... European Commission on,October 30 approved 48-week standard-dose PEGINTRON(TM) (peginterferon,alfa- 2b, ... mg,daily) combination therapy for retreating adult patients with chronic,hepatitis C ...
... largely on children entering school ready to learn, and ... children for school entry. A new study finds that ... for school, suggesting that intervention could help boost readiness ... Laval University, the University of Montreal, and the University ...
... some prescriptions , , WEDNESDAY, Nov. 14 (HealthDay News) -- ... allow certain drugs to be sold by pharmacists without ... to arguments for and against the proposal by representatives ... at the day,s end, the FDA officials said they ...
... Response Genetics, Inc.,(Nasdaq: RGDX ) a company ... cancer, today announced its consolidated financial results for,the ... September 30, 2007. "The third quarter of ... physician and investment communities," said Kathleen Danenberg,President and ...
... Dragon Pharmaceutical Inc.,(TSX: DDD; OTC BB: DRUG; BBSE: ... and nine months ended September 30, 2007, showing ... antibiotic business. Meanwhile,the Company also announced the sale ... a separate press release. Highlights for the ...
... Holdings, Inc. (the,"Company") today announced its operating results for ... Three Months Ended September 30, 2007 Net Revenues ... for the three months,ended September 30, 2007, increased by ... Patient days increased by 289 during the 2007 period.,During ...
Cached Medicine News:Health News:PEGINTRON(TM) and REBETOL(R) Approved in European Union for Retreating Hepatitis C Patients Who Failed Previous Pegylated or Non-Pegylated Interferon Therapy 2Health News:PEGINTRON(TM) and REBETOL(R) Approved in European Union for Retreating Hepatitis C Patients Who Failed Previous Pegylated or Non-Pegylated Interferon Therapy 3Health News:PEGINTRON(TM) and REBETOL(R) Approved in European Union for Retreating Hepatitis C Patients Who Failed Previous Pegylated or Non-Pegylated Interferon Therapy 4Health News:PEGINTRON(TM) and REBETOL(R) Approved in European Union for Retreating Hepatitis C Patients Who Failed Previous Pegylated or Non-Pegylated Interferon Therapy 5Health News:PEGINTRON(TM) and REBETOL(R) Approved in European Union for Retreating Hepatitis C Patients Who Failed Previous Pegylated or Non-Pegylated Interferon Therapy 6Health News:PEGINTRON(TM) and REBETOL(R) Approved in European Union for Retreating Hepatitis C Patients Who Failed Previous Pegylated or Non-Pegylated Interferon Therapy 7Health News:PEGINTRON(TM) and REBETOL(R) Approved in European Union for Retreating Hepatitis C Patients Who Failed Previous Pegylated or Non-Pegylated Interferon Therapy 8Health News:Environment plays key role in children's readiness for school 2Health News:FDA Hears Pros, Cons of Pharmacist-to-Patient Drug Sales 2Health News:FDA Hears Pros, Cons of Pharmacist-to-Patient Drug Sales 3Health News:FDA Hears Pros, Cons of Pharmacist-to-Patient Drug Sales 4Health News:Response Genetics Reports Third Quarter 2007 Financial Results 2Health News:Response Genetics Reports Third Quarter 2007 Financial Results 3Health News:Response Genetics Reports Third Quarter 2007 Financial Results 4Health News:Response Genetics Reports Third Quarter 2007 Financial Results 5Health News:Response Genetics Reports Third Quarter 2007 Financial Results 6Health News:Response Genetics Reports Third Quarter 2007 Financial Results 7Health News:Response Genetics Reports Third Quarter 2007 Financial Results 8Health News:Dragon Achieved Solid Increase in Sales and Profits from Continuing Operations for Q3 2Health News:Dragon Achieved Solid Increase in Sales and Profits from Continuing Operations for Q3 3Health News:Dragon Achieved Solid Increase in Sales and Profits from Continuing Operations for Q3 4Health News:LifeCare Holdings, Inc. Announces Third Quarter Results 2Health News:LifeCare Holdings, Inc. Announces Third Quarter Results 3Health News:LifeCare Holdings, Inc. Announces Third Quarter Results 4Health News:LifeCare Holdings, Inc. Announces Third Quarter Results 5Health News:LifeCare Holdings, Inc. Announces Third Quarter Results 6Health News:LifeCare Holdings, Inc. Announces Third Quarter Results 7Health News:LifeCare Holdings, Inc. Announces Third Quarter Results 8Health News:LifeCare Holdings, Inc. Announces Third Quarter Results 9Health News:LifeCare Holdings, Inc. Announces Third Quarter Results 10Health News:LifeCare Holdings, Inc. Announces Third Quarter Results 11Health News:LifeCare Holdings, Inc. Announces Third Quarter Results 12Health News:LifeCare Holdings, Inc. Announces Third Quarter Results 13Health News:LifeCare Holdings, Inc. Announces Third Quarter Results 14Health News:LifeCare Holdings, Inc. Announces Third Quarter Results 15
Pipetman 8X200 Multichannel Pipette is an eight-channel, fully adjustable, air-displacement pipette having a useful volume range from 20 L to 200 L. Robustwith the usual Gilson qualities this pipette...
Inquire...
... is precision, ergonomics, and value! , ... soft non-slip, contoured handle , Finer control ... action , Stress-free tip ejection with long, ... easy decontamination and sterilization without the need ...
... Lightest Pipettor , , The Shortyavailable with ... of how our face-to-face relationship with the scientific ... that make pipetting easier and more effective., ... pipettors., Gets you closer to the working ...
Medicine Products: