Daiichi Sankyo Announces the Presentation of New Data on LIXIANA® (edoxaban) to be Presented at ESC Congress 2019

- Data presentations from ENTRUST-AF PCI and ETNA-AF add to the
growing body of scientific evidence from the Edoxaban Clinical
Research Programme

- First-time presentation of ENTRUST-AF PCI clincial results
assessing edoxaban in atrial fibrillation (AF) patients following a
successful percutaneous coronary intervention

- Presentations from ETNA-AF programme on real-world use of
edoxaban in regional and European-specific clinical practice include
one-year follow-up of more than 12,500 AF patients in Europe

Munich (ots/PRNewswire) - Daiichi Sankyo Europe GmbH (hereafter,
Daiichi Sankyo) today announced clinical results for edoxaban (known
by the brand name LIXIANA®) will be featured as a late-breaking oral
presentation and as poster presentations at ESC Congress 2019, taking
place from 31 August-04 September in Paris, France.

Clinical results from the ENTRUST-AF PCI study will be presented
during a late-breaking science session at the congress. It is the
first study to evaluate edoxaban in atrial fibrillation (AF) patients
following a successful stent placement for acute coronary syndrome or
stable coronary artery disease. ENTRUST-AF PCI was a multicentre,
prospective, randomised, open-label, blinded-endpoint evaluation
trial performed at 186 sites in 18 countries.1

In addition, five analyses from the global ETNA-AF programme
describing the real-world use of oral, once-daily edoxaban in
regional and European-specific routine clinical practice will be
featured in poster sessions. These analyses will provide important
clinical insights in patients with nonvalvular AF, including elderly
patients, those with extremely low and high body weight, those with
low-, intermediate- and high-risk for stroke and bleeding, and those
with history of intracranial haemorrhage. The programme is comprised
of more than 20,000 patients in Europe, East Asia and Japan followed
for two years and nearly 14,000 patients from 10 European countries
followed for four years.2-7

As part of the Edoxaban Clinical Research Programme, these studies
add to the growing evidence of edoxaban use in a broad range of
cardiovascular conditions, patient types and clinical settings.

Details of the edoxaban-related presentations are as follows:

Presentation Title Presenter Session Details
Late-Breaking Oral
Presentation
Edoxaban-Based Versus Andreas Goette, Tuesday, 03 September
Vitamin-K-Antagonist-Based MDSt. 2019Paris - Main
Anti-Thrombotic Regimen Vincenz-Hospital, Auditorium16:40-17:52
Following Successful Paderborn, Germany
Coronary Stenting in
Atrial Fibrillation
Patients. The ENTRUST-AF
PCI Trial
Poster Presentations
ETNA-AF Europe: First Raffaele De Sunday, 01 September
1-Year Follow-Up Snapshot Caterina, 2019Moderated ePoster
Analysis of More Than MDUniversity of 7 - Poster
7,500 AF Patients Treated Pisa, Pisa, Italy Area10:05-10:55
With Edoxaban in Routine
Clinical Practice
Clinical Characteristics Paulus Kirchhof, Monday, 02 September
and 1-Year Outcomes in MDUniversity of 2019Posters - Poster
Atrial Fibrillation Birmingham, School Area14:00-18:00
Patients With or Without of Clinical and
History of Experimental
IntracranialHaemorrhage Medicine,Birmingham,
Treated With Edoxaban: United Kingdom
Snapshot Analysis of the
Global ETNA-AF Program
One-Year Outcomes of Chun-Chieh Wang, Monday, 02 September
Elderly Patients with MDChang Gung 2019Posters - Poster
Atrial Fbrillation: University, Area14:00-18:00
Snapshot Data from the Department of
Global Cardiology, Taipei,
NoninterventionalProgram Taiwan ROC
on Edoxaban Treatment in
Routine Clinical Practice
in Atrial Fibrillation
Edoxaban Treatment in Thomas Weiss, MDKarl Monday, 02 September
Routine Clinical Practice Landsteiner 2019Posters - Poster
for Patients with Atrial Institute for Area14:00-18:00
Fibrillation (AF) in Cardiometabolics and
Europe (ETNA-AF-Europe): SFU, Vienna, Austria
1-Year Follow-Up According
to Body Mass Index
Stroke and Bleeding in Joris R. de Groot, Monday, 02 September
Low, Intermediate and High MDUniversity of 2019Posters - Poster
Risk Patients With Atrial Amsterdam, Area15:45-16:35
Fibrillation Treated With Amsterdam,
Edoxaban: Results of the Netherlands
ETNA-AF Europe Registry

About ENTRUST-AF PCI

EdoxabaN TReatment VersUS Vitamin K Antagonist in PaTients With
Atrial Fibrillation Undergoing Percutaneous Coronary Intervention
(ENTRUST-AF- PCI) is a prospective, multinational, multicenter,
randomised, open-label with blinded endpoint evaluation phase 3b
study. The ENTRUST-AF PCI trial was designed to evaluate the safety
and accrue exploratory information on the efficacy of an
edoxaban-based antithrombotic regimen compared to a VKA-based
antithrombotic regimen in patients with AF following successful PCI
with stent implantation. The primary objective of the ENTRUST-AF PCI
trial was to compare the incidence of major or clinically relevant
non-major International Society on Thrombosis and Haemostasis
(ISTH)-defined bleeding over a 12-month period of an edoxaban-based
antithrombotic regimen against a VKA-based regimen. 1,506 patients
were enrolled in ENTRUST-AF PCI from 186 clinical sites across Europe
and Asia. Participants were randomly allocated in a 1:1 ratio to a
12-month antithrombotic regimen of edoxaban and a P2Y12 inhibitor or
to a standard therapy with a vitamin K antagonist (VKA) and P2Y12
inhibitor plus acetyl salicylic acid for one to 12 months.1

About ETNA-AF

ETNA-AF (Edoxaban Treatment in routiNe clinical prActice in
patients with nonvalvular Atrial Fibrillation) is a global programme
that combines data from distinct non-interventional studies in
Europe, East Asia, and Japan in a single database. A total of more
than 28,000 patients will be included in the ETNA-AF registries and
followed for two years (patients in Europe will be followed for four
years). The primary objective of ETNA-AF is to collect information on
the use of edoxaban in routine clinical practice, including the
safety and efficacy profile in non-preselected patients with
non-valvular atrial fibrillation (NVAF).2-7

About Atrial Fibrillation

AF is a condition where the heart beats irregularly and rapidly.
When this happens, blood can pool and thicken in the chambers of the
heart causing an increased risk of blood clots. These blood clots can
break off and travel through the blood stream to the brain (or
sometimes to another part of the body), where they have the potential
to cause a stroke.8

AF is the most common type of heart rhythm disorder, and is
associated with substantial morbidity and mortality.9 More than six
million Europeans are diagnosed with AF, and this figure is expected
to at least double over the next 50 years.10,11 Compared to those
without AF, people with the arrhythmia have a 3-5 times higher risk
of stroke.12 One in five of all strokes are a result of AF. 10

About Edoxaban

Edoxaban is an oral, once-daily, direct factor Xa (pronounced "Ten
A") inhibitor. Factor Xa is one of the key components responsible for
blood clotting, so inhibiting this makes the blood thin and less
prone to clotting. Edoxaban is currently marketed by Daiichi Sankyo
and its partners in more than 30 countries and regions around the
world.

About the Edoxaban Clinical Research Programme

More than 10 studies, more than 100,000 patients worldwide

Daiichi Sankyo is committed to expanding scientific knowledge
about edoxaban, as demonstrated through research programmes
evaluating its use in a broad range of cardiovascular conditions,
patient types and clinical settings in atrial fibrillation (AF) and
venous thromboembolism (VTE) designed to further build on the results
of the pivotal ENGAGE-AF and Hokusai-VTE studies. More than 100,000
patients worldwide are expected to participate in the Edoxaban
Clinical Research Programme, which is comprised of more than 10 RCTs
(randomised, controlled trials), registries and non-randomised
clinical studies, including completed, ongoing and future research.
Our goal is to generate new edoxaban clinical and real-world-data
regarding its use in AF and VTE populations, providing physicians and
patients worldwide with greater treatment assurance.

The RCTs include:

- ENGAGE AF-TIMI 48 (Effective aNticoaGulation with factor xA
next GEneration in Atrial Fibrillation), in AF patients at
moderate-to-high risk of thromboembolic events

- Hokusai VTE (Edoxaban in Venous Thromboembolism), in patients
with either acute symptomatic deep vein thrombosis (DVT), pulmonary
embolism (PE) or both

- ENSURE-AF (EdoxabaN vs. warfarin in subjectS UndeRgoing
cardiovErsion of Atrial Fibrillation), in AF patients undergoing
electrical cardioversion

- ENTRUST-AF PCI (EdoxabaN TReatment versUS VKA in paTients with
AF undergoing PCI), in AF patients undergoing percutaneous coronary
intervention

- Hokusai-VTE Cancer (Edoxaban in Venous Thromboembolism
Associated with Cancer), in patients with cancer and an acute VTE
event

- ELDERCARE-AF (Edoxaban Low-Dose for EldeR CARE AF patients), in
elderly AF patients in Japan

- ELIMINATE-AF (EvaLuatIon of edoxaban coMpared with VKA IN
subjects undergoing cAThEter ablation of non-valvular Atrial
Fibrillation)

- ENVISAGE-TAVI AF (EdoxabaN Versus standard of care and theIr
effectS on clinical outcomes in pAtients havinG undergonE
Transcatheter Aortic Valve Implantation (TAVI) - Atrial Fibrillation)

- STABLED Study (STroke secondary prevention with catheter
ABLation and EDoxaban for patients with non-valvular atrial
fibrillation) in Japan

- ENRICH-AF (EdoxabaN foR IntraCranial Hemorrhage survivors with
Atrial Fibrillation, an investigator initiated phase III study)

In addition, global and regional registry and non-randomised
clinical studies provide important real-world and clinical data about
the use of edoxaban and other oral anticoagulants in everyday
practice; these include:

- ETNA-AF (Edoxaban Treatment in routiNe clinical prActice in
patients with nonvalvular Atrial Fibrillation)

- ETNA-VTE (Edoxaban Treatment in routiNe clinical prActice in
patients with Venous ThromboEmbolism)

- EMIT-AF/VTE (Edoxaban Management In diagnostic and Therapeutic
procedures-AF/VTE)

- Prolongation PREFER in AF (PREvention oF thromboembolic events
- European Registry) in patients with AF

- ANAFIE (All Nippon AF In Elderly) Registry in Japan

- Cancer-VTE Registry in Japan

- RYOUMA (Real world ablation therapY with anti-cOagUlants in
Management of Atrial fibrillation) Registry in Japan

- KYU-RABLE (Multicenter study associated with KYU-shu to
evaluate the efficacy and safety of edoxaban in patients with
non-valvulaR Atrial fiBriLlation undergoing cathEter ablation) in
Japan

- BPV-AF (Atrial Fibrillation with BioProsthetic valve) Registry
in Japan

Through the Edoxaban Clinical Research Programme, we are committed
to adding to the scientific body of knowledge around edoxaban in a
variety of AF and VTE patients, including those who are vulnerable.

About Daiichi Sankyo

Daiichi Sankyo Group is dedicated to the creation and supply of
innovative pharmaceutical products to address diversified, unmet
medical needs of patients in both mature and emerging markets. With
over 100 years of scientific expertise and a presence in more than 20
countries, Daiichi Sankyo and its 15,000 employees around the world
draw upon a rich legacy of innovation and a robust pipeline of
promising new medicines to help people. In addition to a strong
portfolio of medicines for hypertension and thrombotic disorders,
under the Group's 2025 Vision to become a "Global Pharma Innovator
with Competitive Advantage in Oncology," Daiichi Sankyo research and
development is primarily focused on bringing forth novel therapies in
oncology, including immuno-oncology, with additional focus on new
horizon areas, such as pain management, neurodegenerative diseases,
heart and kidney diseases, and other rare diseases. For more
information, please visit: www.daiichisankyo.com.

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.

Contact

Lydia Worms (Europe)
Daiichi Sankyo Europe GmbH
Edoxaban Communications & Product PR Europe
+49 (89) 7808751

References

1. Edoxaban Treatment Versus Vitamin K Antagonist in Patients With
Atrial Fibrillation Undergoing Percutaneous Coronary Intervention
(ENTRUST-AF-PCI). Available at:
https://clinicaltrials.gov/ct2/show/NCT02866175. [Last accessed:
August 2019].
2. Edoxaban Treatment in Routine Clinical Practice for Patients With
Non Valvular Atrial Fibrillation (ETNA-AF-EU). Available at:
https://clinicaltrials.gov/ct2/show/NCT02944019. [Last accessed:
August 2019].
3. Edoxaban Treatment in Routine Clinical Practice for Patients With
Atrial Fibrillation in Korea and Taiwan (ETNA-AF-KOR-TWN).
Available at: https://clinicaltrials.gov/ct2/show/NCT02951039.
[Last accessed: August 2019].
4. Edoxaban Treatment in Routine Clinical Practice for Patients With
Non-valvular Atrial Fibrillation (ETNA-AF-Hong Kong). Available
at: https://clinicaltrials.gov/ct2/show/NCT03247582. [Last
accessed: August 2019].
5. Edoxaban Treatment in Routine Clinical Practice for Patients With
Non-Valvular Atrial Fibrillation (NVAF). Available at:
https://clinicaltrials.gov/ct2/show/NCT03247569. [Last accessed:
August 2019].
6. ETNA-AF-Japan. Available at: https://upload.umin.ac.jp/cgi-open-b
in/ctr/ctr_view.cgi?recptno=R000019728 [Last accessed: August
2019].
7. De Caterina et al. BMC Cardiovascular Disorders (2019) 19:165
8. National Heart, Lung and Blood Institute - What is Atrial
Fibrillation. Available at:
http://www.nhlbi.nih.gov/health/dci/Diseases/af/af_diagnosis.html
. [Last accessed: August 2019].
9. Iqbal MB, et al. Recent developments in atrial fibrillation. BMJ.
2005;330(7485):238-43.
10. Camm A, et al. Guidelines for the management of atrial
fibrillation: the Task Force for the Management of Atrial
Fibrillation of the European Society of Cardiology (ESC). Eur
Heart J. 2010;31(19):2369-2429.
11. Krijthe BP, et al. Projections on the number of individuals with
atrial fibrillation in the European Union, from+- 2000 to 2060.
Eur Heart J. 2013;34(35):2746-2751.
12. Ball J, et al. Atrial fibrillation: Profile and burden of an
evolving epidemic in the 21st century. Int J Card.
2013;167:1807-1824.

EDX/19/0538, Date of preparation: August 2019

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