Daiichi Sankyo Initiates ENVISAGE-TAVI AF Study Investigating Once-Daily LIXIANA® (edoxaban) in Patients with Atrial Fibrillation Undergoing Transcatheter Aortic Valve Implantation

Munich (ots/PRNewswire) -

- ENVISAGE-TAVI AF is the first study to evaluate the effects of a
novel oral anticoagulant on clinical outcomes exclusively in atrial
fibrillation patients following successful transcatheter aortic
valve implantation
- Study adds to the growing Edoxaban Clinical Research Programme
(ECRP) evaluating its use in a broad range of cardiovascular
conditions, patient types and clinical settings

Daiichi Sankyo Europe GmbH (hereafter, "Daiichi Sankyo") today
announced that the first patient has been enrolled into the
ENVISAGE-TAVI AF study. The multinational, randomised phase 3b study
will evaluate a treatment regimen based on the company's oral,
once-daily direct factor Xa-inhibitor edoxaban (known by the brand
name LIXIANA® outside the US and SAVAYSA® in the US) against a
vitamin K antagonist based regimen, with or without antiplatelet
therapy, in patients with atrial fibrillation (AF) following
successful transcatheter aortic valve implantation (TAVI). The study
will investigate the incidence of net adverse clinical events (NACE),
including the composite of all-cause death, myocardial infarction
(MI), ischaemic stroke, systemic thromboembolism (SEE), valve
thrombosis, and major bleeding (International Society on Thrombosis
and Haemostasis [ISTH] definition). Approximately 1,400 patients will
be enrolled in ENVISAGE-TAVI AF from 200 clinical sites across
Europe, the United States and Canada.[1]

"ENVISAGE-TAVI AF is a very important study because it will
provide the first clinical evidence comparing the safety and efficacy
of an edoxaban-based versus a VKA-based regimen in non-valvular AF
patients with indication for chronic oral anticoagulation after
successful TAVI in a sufficiently powered study. In this study,
edoxaban will be used with the approved dosage regimen for stroke
prevention in atrial fibrillation," said George Dangas, MD, PhD,
Professor of Medicine, Mount Sinai School of Medicine and
co-principal study investigator.

Transcatheter aortic valve implantation (TAVI) has become an
increasingly frequent procedure to treat aortic stenosis.[2] Aortic
stenosis is a progressing disease, and may turn into a life
threatening condition.[3] In patients undergoing a TAVI procedure, AF
is a frequent comorbidity which requires chronic oral anticoagulation
therapy.[4],[5]

"At present, ENVISAGE-TAVI AF is the only study of patients
undergoing TAVI designed to compare exclusively non-valvular AF
patients on a novel oral anticoagulant regimen against a VKA-based
regimen," said Nicolas M. van Mieghem, MD, PhD, Erasmus University of
Rotterdam and co-principal investigator.

"ENVISAGE-TAVI AF will add to the growing body of evidence in the
Edoxaban Clinical Research Programme, providing unique insights into
the potential benefit of edoxaban in atrial fibrillation patients
undergoing TAVI procedures, a high-risk population," said Hans J.
Lanz, MD, Executive Director, Global Medical Affairs, Daiichi Sankyo.

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About ENVISAGE-TAVI AF

EdoxabaN Versus standard of care and theIr effectS on clinical
outcomes in pAtients havinG undergonE Transcatheter Aortic Valve
Implantation - in Atrial Fibrillation (ENVISAGE-TAVI AF) is a
prospective, randomised, open-label, blinded endpoint evaluation,
parallel-group phase 3b study, evaluating the efficacy and safety of
once-daily edoxaban against a regimen of a vitamin K antagonist, with
or without antiplatelet therapy, in AF patients following successful
transcatheter aortic valve implantation (TAVI). The primary efficacy
endpoint is incidence of net adverse clinical events (NACE), i.e.,
the composite of all-cause death, MI, ischemic stroke, SEE, valve
thrombosis, and major bleeding (International Society on Thrombosis
and Haemostasis [ISTH] definition). The primary safety endpoint is
major bleeding (ISTH definition). Approximately 1,400 patients will
be enrolled in ENVISAGE-TAVI AF from 200 clinical sites across
Europe, the United States and Canada. Edoxaban will be used with the
approved dosage regimen for stroke prevention in AF in each
country.[1]

For more information, please visit:
https://clinicaltrials.gov/ct2/show/NCT02943785.

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.[6]

AF is the most common type of heart rhythm disorder, and is
associated with substantial morbidity and mortality.[7] An estimated
8.8 million Europeans suffered from AF in 2010, and this figure is
expected to at least double over the next 50 years.[8] Compared to
those without AF, people with the arrhythmia have a 3-5 times higher
risk of stroke.[9] One in five of all strokes are as a result of
AF.[5]

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 in Japan, the U.S.,
South Korea, Hong Kong, Taiwan, Thailand, Switzerland, the U.K.,
Germany, Ireland, the Netherlands, Italy, Spain, Belgium, Austria,
Portugal, and other European countries.

The edoxaban Summary of Product Characteristics can be viewed
here:

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Produc
t_Information/human/002629/WC500189045.pdf.

About Edoxaban Clinical Research Programme (ECRP)

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 atrial fibrillation (AF) and
venous thromboembolism (VTE). The Edoxaban Clinical Research
Programme includes multiple RCTs (randomised, controlled trials),
registries and non-interventional studies, with the goal of
generating new clinical and real-world-data regarding its use in AF
and VTE populations. Daiichi Sankyo expects that more than 100,000
patients will participate in the Edoxaban Clinical Research
Programme, including completed, ongoing and future research.

The RCTs include:

- 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 non valvular 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

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.

Daiichi Sankyo Fights Thrombosis

Daiichi Sankyo is your partner in antithrombotic therapy with the
discovery and development of innovative products, to help patients
with a wide range of cardiovascular conditions. These include EFIENT®
(prasugrel) for acute coronary syndromes and LIXIANA® (edoxaban) for
non-valvular atrial fibrillation, deep vein thrombosis and pulmonary
embolism. Daiichi Sankyo's ongoing commitment in this field is
demonstrated by their continued investment into patient-relevant
clinical development activities that aim to advance the care and
improve the lives of people suffering with these diseases. For more
information, please visit: http://www.daiichi-sankyo.eu.

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 16,000 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: http://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. Clinicaltrials.gov. Edoxaban Compared to Standard Care After Heart
Valve Replacement Using a Catheter in Patients With Atrial
Fibrillation (ENVISAGE-TAVI AF). Available at:
https://clinicaltrials.gov/ct2/show/NCT02943785. [Last accessed:
April 2017].
2. Webb J, Cribier A. Percutaneous transarterial aortic valve
implantation: what do we know? Eur Heart J. 2011;32(2):140-7.
3. Otto CM, Prendergast B. Aortic-valve stenosis- from patients at
risk to severe valve ablation. N Engl J Med. 2104;371(8):744-56.
4. Biviano AB, et al. Atrial fibrillation is associated with
increased mortality in patients undergoing transcatheter aortic
valve replacement: insights from the placement of aortic
transcatheter valve (PARTNER) trial. Circ Cardiovasc Interv.
2016;9(1):e002766. doi:10.1161/CIRCINTERVENTIONS. 115.002766.
5. Kirchhof P, et al. 2016 ESC Guidelines for the management of
atrial fibrillation developed in collaboration with EACTS. Eur
Heart J. 2016;37(38):2893-2962.
6. 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: April 2017].
7. Iqbal MB, et al. Recent developments in atrial fibrillation. BMJ.
2005;330(7485):238-43.
8. 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.
9. Ball J, et al. Atrial fibrillation: Profile and burden of an
evolving epidemic in the 21st century. Int J Card.
2013;167:1807-1824.

Contact

Lydia Worms (Europe)

Daiichi Sankyo Europe GmbH

Edoxaban Communications & Product PR Europe

+49-(89)-7808751

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