LIXIANA® (edoxaban) Shows Reduced Rate of a Variety of Types of Intracranial Haemorrhage Compared to Warfarin in New Sub-analysis Presented at the European Stroke Organisation Conference 2018

Munich (ots/PRNewswire) -

- Sub-analysis presented from ENGAGE AF-TIMI 48, the longest single
comparative global trial of a non-vitamin K oral anticoagulant
(NOAC) in patients with non-valvular atrial fibrillation (NVAF) to
date
- Results showed a reduction in both spontaneous and traumatic
intracranial haemorrhage (ICH) in patients who took edoxaban,
compared to warfarin[1]
- The data is being presented at the European Stroke Organisation
Conference (ESOC) 2018, in Gothenburg, Sweden

Daiichi Sankyo Europe GmbH (hereafter, Daiichi Sankyo), today
announced new sub-analysis data from the ENGAGE AF-TIMI 48 trial,
which demonstrates that patients with atrial fibrillation (AF)
treated with edoxaban (known by the brand name LIXIANA®?), for the
prevention of stroke or systemic embolic events (SEE), had reduced
rates of different types of intracranial haemorrhage (ICH, bleeding
inside the skull),[2] compared to those on warfarin.[1] The data was
presented at the 4th European Stroke Organisation Congress (ESOC), on
16-18 May, in Gothenburg, Sweden.

Providing insights on the rates of ICH by cause, the sub-analysis
showed a 42% reduction in spontaneous ICH (HR 0.58 [0.41-0.81]),
which occurred in 97 patients taking either edoxaban or warfarin, and
a 62% reduction in traumatic ICH (HR 0.38 [0.23-0.63]), which
occurred in 185 patients taking either edoxaban or warfarin, among
patients taking edoxaban (60 mg or 30 mg dose reduced, once-daily)
compared to warfarin.[1] These results build on the body of evidence
supporting the use of edoxaban in clinical practice and follow
results from the ENGAGE-AF-TIMI 48 trial, where edoxaban demonstrated
non-inferiority to warfarin for the prevention of stroke or SEE in
patients with AF, with significant reductions in cardiovascular
mortality and major bleeding.[3]

"Non-vitamin K antagonist oral anticoagulants are increasingly
used in clinical practice, and it is essential that we continue to
expand our understanding of these therapies in specific patient
populations, to help inform and optimise care" said co-author of
study Robert P. Giugliano, from the Division of Cardiovascular
Medicine, Brigham and Women's Hospital, Harvard Medical School,
Boston, USA. "Results from the sub-analysis of the ENGAGE AF-TIMI 48
trial suggest that edoxaban offers an advantage over warfarin in
patients who need anticoagulation and are at risk of ICH, providing
guidance and offering further assurance to physicians regarding its
use."

ICH is a type of bleeding that occurs inside the skull, either
within the brain parenchyma or the surrounding meningeal spaces.[2]
It can have serious life-long implications for patients, and the
mortality rate in ICH is three times that of ischemic stroke.[4]

The sub-analysis provides further insights into outcomes in
edoxaban compared to warfarin by ICH subtype, with edoxaban (60 mg or
30 mg dose reduced, once-daily) treated patients having lower rates
of intraparenchymal haemorrhage (IPH) (HR 0.55 [95% CI 0.38-0.78])
and subdural hematoma (SDH) (HR 0.36 [0.22-0.58]), and similar rates
of subarachnoid haemorrhage (SAH) and ischemic stroke with
haemorrhagic transformation (ISHT) (both p>0.05).[1]

"These data provide further insights into the benefits of edoxaban
and its use to achieve the best possible outcomes for AF patients,"
said Wolfgang Zierhut, MD, Head of Antithrombotic & Cardiovascular
Therapeutic Area, Daiichi Sankyo Europe. "We remain committed to
advancing understanding of edoxaban and this data adds to the growing
body of evidence supporting its use."

These latest sub-analysis findings from the ENGAGE AF-TIMI 48
trial align with the '2018 European Heart Rhythm Association guide on
the use of non-vitamin K antagonist oral anticoagulants in patients
with atrial fibrillation', published in March 2018. The guidelines
recommend NOACs over warfarin for the prevention of stroke in
eligible AF patients, due to the reduced risk of intracranial and
life-threatening bleeds, which has been consistently observed across
multiple studies.[5]

About the ENGAGE AF-TIMI 48 Study

ENGAGE AF-TIMI 48 (Effective aNticoaGulation with factor xA next
GEneration in Atrial Fibrillation) was a three-arm, randomised,
double-blind, double-dummy, global phase 3 clinical trial comparing
once-daily edoxaban with warfarin in 21,105 patients with NVAF at
moderate-to-high risk of thromboembolic events at 1,393 centres in 46
countries. ENGAGE AF-TIMI 48 compared two edoxaban treatment
strategies, a higher dose arm (60 mg or 30 mg dose reduced)
once-daily and a lower dose arm (30 mg or 15 mg dose reduced, which
is not currently licensed) once-daily, with warfarin in patients with
NVAF for a median of 2.8 years. Patients were dose reduced for
creatinine clearance (CrCL) 30 to 50 mL/min, body weight of 60 kg or
less or certain p-glycoprotein inhibitor use. ENGAGE AF-TIMI 48
represents the longest single comparative global trial with a novel
anticoagulant in patients with NVAF performed to date. The full
results were presented at the AHA Scientific Sessions 2013 in Dallas
and published in the New England Journal of Medicine.[3]

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, Canada, 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_-_Pro
duct_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 AF and 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.

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: 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. Nelson, S.E. et al. Intracranial haemorrhage in patients with
atrial fibrillation receiving oral anticoagulation with warfarin
or edoxaban. Abstract presented at ESOC Congress 2018.
2. Caceres, A.J., Goldstein, J.N. Intracranial Hemorrhage. Emerg Med
Clin North Am. 2012;30(3):771-794.
3. Giugliano, RP et al. Edoxaban versus Warfarin in Patients with
Atrial Fibrillation. N Engl J Med. 2013;369:2093-104.
4. The Risk of Intracranial Hemorrhage with Anticoagulation in the
Elderly - Estimates of Prevalence and Therapeutic Strategies,
2015. Available at: http://www.acc.org/latest-in-cardiology/articl
es/2015/12/21/12/59/the-risk-of-intracranial-hemorrhage-with-antic
oagulation-in-the-elderly . [last accessed: May 2018].
5. Steffel, J, et al. The 2018 European Heart Rhythm Association
Practical Guide on the use of non-vitamin K antagonist oral
anticoagulants in patients with atrial fibrillation. European
Heart Journal. 2018;21;39(16):1330-1393.

Contact

Lydia Worms (Europe)

Daiichi Sankyo Europe GmbH

Edoxaban Communications & Product PR Europe

+49(89)7808751

EDX/18/0240

Date of preparation: May 2018

ots Originaltext: Daiichi Sankyo Europe GmbH
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Original-Content von: Daiichi Sankyo Europe GmbH, übermittelt durch news aktuell