Daiichi Sankyo Presents Positive Results of the First Randomised, Controlled Trial of Uninterrupted Oral, Once-daily LIXIANA® (edoxaban) in Atrial Fibrillation Patients Undergoing Catheter Ablation

Munich (ots/PRNewswire) -

- ELIMINATE-AF is the first set of data presented in 2019 from the
Edoxaban Clinical Research Programme, which will deliver new
evidence to support the use of edoxaban in clinical practice
- Late-breaking data presented at EHRA 2019, the annual congress of
the European Heart Rhythm Association, shows ELIMINATE-AF met
primary efficacy and safety objectives, demonstrating low
thromboembolic and bleeding event rates1
- ELIMINATE-AF provides evidence that uninterrupted LIXIANA®
(edoxaban) treatment represents an alternative to continuous
anticoagulation with VKA in patients undergoing catheter ablation
of AF

Daiichi Sankyo Company, Limited (hereafter, "Daiichi Sankyo")
today announced results from ELIMINATE-AF, a prospective, randomised,
open label, blinded endpoint evaluation (PROBE) design study
assessing the safety and efficacy of uninterrupted oral, once-daily
edoxaban (known by the brand name LIXIANA®) 60 mg versus
uninterrupted vitamin K antagonists (VKA) in atrial fibrillation (AF)
patients undergoing catheter ablation. The study showed the
uninterrupted anticoagulation regimen with edoxaban in patients
undergoing catheter ablation resulted in low event rates for both
thromboembolic and bleeding events.1 The data were presented today
during a late-breaker session at EHRA 2019, the annual congress of
the European Heart Rhythm Association, in Lisbon, Portugal.

The primary efficacy objective of ELIMINATE-AF was to compare
descriptively the time to first all-cause death, stroke, or
International Society on Thrombosis and Haemostasis (ISTH)-defined
major bleeding, assessed in the per-protocol population from the end
of ablation procedure to the end of treatment. The incidence of the
primary endpoint was 0.3% (1/316) in the edoxaban group and 2.0%
(2/101) in the VKA group (HR 0.16; 95% CI 0.02, 1.73). The event rate
was low and similar in both treatment arms; most events were
procedure -related. All three events were major bleedings, and there
were no deaths in the study. Edoxaban adherence was excellent (>97%)
and VKA treatment was well managed.1

The primary safety objective was to compare descriptively the
incidence of ISTH-defined major bleeding in the edoxaban group
against the VKA group in the period from date of first intake of
study medication to end of treatment/Day 90. The primary safety
endpoint in the mITT (modified Intent to Treat) population occurred
in 2.5% (10/405) in the edoxaban group and 1.5% (3/197) in the VKA
group (HR 1.68; 95 CI 0.46, 6.07).

"Catheter ablation is a common and effective procedure for rhythm
control in patients with symptomatic AF. However, the procedure is
associated with a significant thromboembolic risk during and shortly
after the procedure, requiring systemic anticoagulation before,
during, and after ablation," said Stefan Hohnloser, MD, Professor of
Medicine and Cardiology, Head, Department of Electrophysiology,
Johann Wolfgang Goethe University in Frankfurt, Germany, and
principal study investigator. "These results provide evidence that
uninterrupted edoxaban treatment represents an alternative to
continuous anticoagulation with VKA in patients undergoing catheter
ablation of AF. This is significant for this complex patient
population and physicians because the management of anticoagulation
around ablation is much easier with once-daily edoxaban, with low
potential of interaction with concomitant drugs."

Until recently, there has been a lack of data to support the
uninterrupted peri-procedural use of non-VKA, oral anticoagulants
(NOACs) during AF ablation. ELIMINATE-AF was the first randomised
controlled trial on the use of edoxaban for catheter ablation of AF.

"We are encouraged by these results, which represent an important
potential advancement in the way we manage thromboembolic risk
surrounding catheter ablation," said Hans Lanz, MD, Vice President,
Head, Global Medical Affairs Edoxaban, Daiichi Sankyo Europe GmbH.
"ELIMINATE-AF will help define the role of uninterrupted therapy with
edoxaban in the clinical setting of catheter ablation of AF. These
results are the first of a broad set of data to be presented in 2019
supporting the use of edoxaban in specific clinical situations and
the real-world setting."

ELIMINATE-AF is one of more than 10 randomised, controlled trials
(RCTs), registries and non-interventional studies that comprise the
Edoxaban Clinical Research Programme. More than 100,000 patients
worldwide are expected to participate in the Edoxaban Clinical
Research Programme studies, the goal of which is to generate new
clinical and real-world data regarding its use in AF and venous
thromboembolism (VTE) populations, providing physicians and patients
worldwide with greater treatment confidence.

About ELIMINATE-AF

EvaLuatIon of Edoxaban coMpared with VKA INsubjects undergoing
cAThEter ablation of non-valvular Atrial Fibrillation (ELIMINATE-AF)
was a prospective, randomised, open-label, blinded endpoint
evaluation, parallel-group phase 3b study to evaluate the efficacy
and safety of once-daily edoxaban against a vitamin K antagonist in
AF patients undergoing catheter ablation of AF. The primary objective
was to descriptively compare the incidence of the composite of
all-cause death, stroke (ischemic, hemorrhagic, or undetermined) and
major bleeding (ISTH definition) in the edoxaban group against the
vitamin K antagonist group in the period from the end of the catheter
ablation procedure to Day 90/end-of-treatment (EOT). The primary
safety objective was to descriptively compare the incidence of major
bleeding (ISTH definition) in the edoxaban group against the VKA
group in the period from date of first intake of study medication to
Day 90/EOT. Approximately 600 patients were enrolled in ELIMINATE-AF
from more than 70 clinical sites across Europe, Canada and Asia.
Patients were randomised (2:1) to receive edoxaban or VKA for 21 to
28 days pre- and 90 days post-ablation period.2

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.3

AF is the most common type of heart rhythm disorder and is
associated with substantial morbidity and mortality.4 More than six
million Europeans are diagnosed with AF, and this figure is expected
to at least double over the next 50 years.5,6 Compared to those
without AF, people with the arrhythmia have a 3-5 times higher risk
of stroke.7 One in five of all strokes are a result of AF.8

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 20 countries 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 our research programmes
evaluating its use in a broad range of cardiovascular conditions,
patient types and clinical settings in AF and venous 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-interventional studies, including completed,
ongoing and future research. The goal is to generate new 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)

In addition, global and regional registry studies will provide
important real-world data about the use of edoxaban and other oral
anticoagulants in everyday practice, and 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

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.

For more information, please visit:
https://www.daiichisankyo.com/rd/pipeline/products/ecrp/index.html

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.

References

1. Hohnloser SH, et al. Uninterrupted Edoxaban versus Vitamin K
Antagonists for Ablation of Atrial Fibrillation: The ELIMINATE-AF
Trial. EHRA Annual Meeting Abstracts [https://bit.ly/2C85lPO]
2. Clinicaltrials.gov. Edoxaban Treatment Versus Vitamin K Antagonist
(VKA) in Patients With Atrial Fibrillation (AF)Undergoing Catheter
Ablation (ELIMINATE-AF). Available at
https://clinicaltrials.gov/ct2/show/NCT02942576. Last accessed
February 2019.
3. 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 February 2019.
4. Iqbal MB, et al. Recent developments in atrial fibrillation. BMJ.
2005;330(7485):238-43.
5. Kirchof P, et al. 2016 ESC Guidelines for the management of atrial
fibrillation developed in collaboration with EACTS. Eur Heart J.
2016;37, 2893-2962.
6. 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.
7. Ball J, et al. Atrial fibrillation: Profile and burden of an
evolving epidemic in the 21st century. Int J Card.
2013;167:1807-1824.
8. 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.

March 2019 Job Code: EDX/19/0108

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

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