UK's NICE Recommends Once-daily LIXIANA® (edoxaban) for Preventing Stroke and Systemic Embolism in Patients with Non-valvular Atrial Fibrillation

Tokyo (ots/PRNewswire) -

The National Institute for Health and Care Excellence (NICE), the
medicines cost-effectiveness body for England and Wales, has
recommended a new treatment to help prevent stroke and systemic
embolism (SE) in patients suffering from the heart rhythm disorder
atrial fibrillation (AF).[1]

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today
announced that NICE has issued its final recommendation for
LIXIANA(R) (edoxaban) for preventing stroke and SE in patients with
non-valvular atrial fibrillation (NVAF). This follows NICE's
publication of a Final Appraisal Document (FAD) on 6 August 2015, for
its Single Technology Appraisal (STA) of LIXIANA for the prevention
of stroke and SE in patients with NVAF.[2]

The NICE recommendation comes shortly after LIXIANA received
European marketing authorisation in June 2015 for two indications:

- Prevention of stroke and SE in adult patients with NVAF with one or more risk
factors, such as congestive heart failure, hypertension, age greater than or equal to
75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA)
- Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of
recurrent DVT and PE in adults. The NICE final recommendation for this indication was
obtained on 26 August 2015

The final NICE recommendation states: "Edoxaban is recommended,
within its marketing authorisation, as an option for preventing
stroke and systemic embolism in adults with non-valvular atrial
fibrillation with one or more risk factors, including congestive
heart failure, hypertension, diabetes, prior stroke or transient
ischaemic attack, or age 75 years or older." It adds: "The Committee
concluded that taking all of the analyses into account, edoxaban was
cost effective compared with warfarin and could be recommended as an
alternative to warfarin for preventing stroke and systemic embolism
in people with non-valvular atrial fibrillation who have one or more
risk factors for stroke."[1]

Edoxaban, made by the pharmaceutical company Daiichi Sankyo, is
one of the class of blood-thinning drugs known as novel oral
anticoagulants (NOACs). These drugs are used as an alternative to
warfarin, which has been widely used for over 50 years but requires
frequent monitoring to ensure the drug is working properly and is
also associated with many food and drug interactions.[3]

The final NICE recommendation noted: "The Committee accepted the
limitations of warfarin therapy and the considerable impact it may
have on people who take it, and recognised the potential benefits of
edoxaban for people with non-valvular atrial fibrillation," and
concluded that, "edoxaban was as clinically effective as warfarin for
the primary efficacy outcome of reducing stroke (ischaemic and
haemorrhagic) and systemic embolism, and had nearly half the rate of
haemorrhagic stroke events compared to warfarin."[1]

Professor Martin Cowie, Professor of Cardiology at Imperial
College London and noted researcher of AF, said edoxaban gives
doctors the ability to better tailor medicines to individual
patients.

"A few years ago, all we had to prevent strokes in AF patients was
warfarin, which imposes many lifestyle restrictions on patients and
needs monitoring with a blood test system measuring International
Normalised Ratio (INR). Now we have choices with modern
blood-thinning drugs that do not need INR monitoring and are easy for
patients to live with."

Dr. Simon Clough, UK Managing Director for Daiichi Sankyo, said:
"We are very pleased to be able to offer patients and doctors in
England and Wales a new convenient alternative in the treatment
armoury against AF-related illness. NICE has recognised an unmet
clinical need among patients with AF and this recommendation confirms
the value of LIXIANA, which combines convenience and safety compared
to well managed warfarin with features that patients and physicians
appreciate."

AF is the most common type of heart rhythm disorder, and is
associated with substantial morbidity and mortality.[4] According to
NICE, the estimated prevalence of AF in England is 1.6% of adults
aged 18 or over, which equates to approximately 835,000 cases. Of
these 835,000 cases, between 476,000 and 702,000 adults could require
anticoagulation therapy.[5] In addition, there may be another 250,000
people who are undiagnosed.[6] According to NICE, only an estimated
49.3% of patients with a history of AF are currently receiving
anticoagulation therapy.[5]

AF affects approximately 2.3-3.4% of people in developed
nations.[7] More than six million Europeans are diagnosed with AF,
and this figure is expected to at least double over the next 50
years.[8],[9] One in five of all strokes are as a result of AF.[8]
Stroke is the second most common cause of death worldwide,
responsible for approximately 6.7 million deaths each year.[10]

About AF

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.[11]

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.

The ENGAGE AF-TIMI 48 global phase 3 study investigated once-daily
edoxaban in comparison to warfarin in 21,105 patients with NVAF. This
represented the largest and longest trial with a NOAC in patients
with AF performed to date, with a median follow-up of 2.8 years.[12]
Edoxaban demonstrated non-inferiority for stroke or SE.[12] Edoxaban
was also found to be superior for the principal safety endpoint of
major bleeding in comparison to warfarin.[12]

Appropriate Use of Edoxaban

Haemorrhage is a common adverse effect of all anticoagulants.

- Special care should be taken when deciding to prescribe edoxaban to patients with
other conditions, procedures, and concomitant treatments, which may increase the risk
of major bleeding
- As such, a detailed prescriber guide has been made available to HCPs to ensure correct
use of the drug
- In addition, every pack contains a patient alert card which can help alert treating
HCPs in the case of routine or emergency interventions

The prescriber guide and a full list of contraindications,
warnings and information on posology can be found in the edoxaban
summary of product characteristics at
https://www.medicines.org.uk/emc/medicine/30506

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 17,000 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 its strong
portfolio of medicines for hypertension, dyslipidemia, bacterial
infections, and thrombotic disorders, the Group's research and
development is focused on bringing forth novel therapies in
cardiovascular-metabolic diseases, pain management, and oncology,
including biologics. 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) NICE. Edoxaban for preventing stroke and systemic embolism in people with
non-valvular atrial fibrillation. Issued September 2015, TA 355. Available at:
http://www.nice.org.uk/guidance/ta355.
2) NICE. Final appraisal determination: Edoxaban for preventing stroke and systemic
embolism in people with non-valvular atrial fibrillation. Issued 6 August 2015.
Available at:
https://www.nice.org.uk/guidance/gid-tag475/resources/atrial-fibrillation-nonvalvular-
edoxaban-tosylate-id624-final-appraisal-determination-document2.
3) Lip G, et al. Apixaban versus edoxaban for stroke prevention in nonvalvular atrial
fibrillation. J. Comp. Eff. Res. (2015) 4(4), 367-376.
4) Iqbal MB, et al. Recent developments in atrial fibrillation. BMJ. 2005;330(7485)
:238-43.
5) NICE. Support for commissioning anticoagulant therapy. Commissioning guide 49. Issued
14 May 2013. Available at:
http://www.nice.org.uk/guidance/cmg49/resources/non-guidance-support-for-commissioning
-anticoagulation-therapy-pdf.
6) NICE. Thousands of strokes in people with common heart rhythm disorder are avoidable,
says NICE. Press release issued 18 June 2014.
7) Ball J, et al. Atrial fibrillation: Profile and burden of an evolving epidemic in the
21st century. Int J Cardiol. 2013;167: 1807-24.
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.
9) 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.
10) World Health Organization. The top 10 causes of death. Available at:
http://www.who.int/mediacentre/factsheets/fs310/en/index2.html [Last accessed:
September 2015].
11) 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:
September 2015].
12) Giugliano R, et al. Edoxaban versus warfarin in patients with atrial fibrillation. N
Engl J Med. 2013;369(22):2093-2104.

Contact
Lydia Worms (Europe)
Daiichi Sankyo Europe GmbH
Edoxaban Communications & Product PR Europe
+49(89)7808751
EmptyBreak:MARKER
Yasuki Minobe (Global)
Daiichi Sankyo Group
Corporate Communications Department
+81(3)62251126

ots Originaltext: DAIICHI SANKYO EUROPE GmbH
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