UK's NICE Recommends Once-daily LIXIANA® (Edoxaban) for the Treatment and Prevention of Recurrent Deep Vein Thrombosis and Pulmonary Embolism in Adults

Tokyo (ots/PRNewswire) -

The National Institute for Health and Care Excellence (NICE), the
medicines cost-effectiveness body for England and Wales, has today
recommended a new treatment to help patients suffering from blood
clots in the legs and lungs.[1]

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today
announced that NICE has issued its final recommendation for
LIXIANA(R) (edoxaban) for the treatment and prevention of recurrent
deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults.

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

- Treatment of DVT and PE, and prevention of recurrent DVT and PE in adults
- Prevention of stroke and systemic embolism (SE) in adult patients with nonvalvular
atrial fibrillation (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)

The final NICE recommendation states: "Edoxaban is recommended,
within its marketing authorisation, as an option for treating and for
preventing recurrent deep vein thrombosis and pulmonary embolism in
adults."[1] It adds: "The Committee concluded that edoxaban could be
recommended as a cost-effective use of National Health Service (NHS)
resources." [1]

On August 6, 2015, NICE also published a Final Appraisal
Determination (FAD) for its Single Technology Appraisal (STA) of
LIXIANA(R) for the prevention of stroke and SE in people with
NVAF.[2]

Edoxaban, invented by the pharmaceutical company Daiichi Sankyo,
is a member of the class of blood-thinning drugs known as novel oral
anticoagulants (NOACs). The 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 or drug interactions.

Once daily edoxaban is initiated after a five day lead in with
heparin treatment, in line with current clinical practice. In the
pivotal Hokusai-VTE study, edoxaban was shown to have proven efficacy
and a significantly better bleeding profile than well-managed
warfarin.[3]

The term venous thromboembolism (VTE) is used to cover both DVT
and PE. VTE is associated with considerable clinical burden related
to recurrence and complications including post-thrombotic syndrome
and pulmonary hypertension, and is often fatal. The number of
casualties in Europe annually due to VTE is double that of people who
die of breast cancer, prostate cancer, AIDS and traffic accidents
combined.[4]

There is a high rate of recurrence after a first VTE event, which
is reduced with anticoagulant treatment. Without anticoagulant
treatment, approximately half of patients who experience an initial
VTE event have recurrent VTE within three months.[5]

According to NICE, there are approximately 83,500 new cases of VTE
each year in England. This equates to approximately one case per 500
people (200 cases per 100,000).[6] In addition to new annual cases,
there is another group of approximately 42,000 patients needing
long-term anticoagulation treatment.[6]

A 2007 study of morbidity and mortality from VTE in six European
countries (France, Germany, Italy, Spain, Sweden and the UK)
estimated a total of approximately 762,000 VTE episodes and a further
370,000 VTE-related deaths each year. Of these deaths, almost 60%
followed undiagnosed and untreated VTE, which suggests that effective
treatment could prevent many VTE-related deaths.[4]

Dr Alexander Cohen, Consultant Vascular Physician from Guy's and
St Thomas' Hospitals, Kings College London, who has researched
edoxaban for VTE, welcomed an additional resource to tackle the
condition.

"No two patients are identical and what suits one may not suit
another. Venous thromboembolism has a high rate of recurrence, which
can be fatal. We need more tools to protect patients from a second
incident and edoxaban will be of great use to doctors to help tailor
treatments to specific patients."

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 and convenient-to-use alternative in the
treatment armoury against VTE. It is gratifying that NICE has found
our therapy to be clinically effective and cost effective shortly
after receiving our European authorisation."

About VTE

VTE is a condition in which a blood clot (a thrombus) forms in a
vein, most commonly in the deep veins of the legs or pelvis. This is
known as DVT.[7] The thrombus can dislodge and travel in the blood
(an embolus), particularly to the pulmonary (lung) arteries. This is
known as PE. The term VTE includes both DVT and PE.[7] Venous
thromboembolic diseases cover a spectrum ranging from asymptomatic
calf vein thrombosis to symptomatic DVT. They can be fatal if they
lead to PE, in which the blood supply to the lungs is blocked by the
thrombus. Non-fatal VTE can cause serious long-term conditions such
as post-thrombotic syndrome.[7]

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.

The global phase 3 Hokusai-VTE study investigated 8,292 patients
with either acute symptomatic DVT, PE, or both. This represented the
largest single VTE study carried out to date with a NOAC in this
indication.[3]

The study found that edoxaban met the primary efficacy endpoint of
non-inferiority compared to warfarin, following initial use of
heparin in both arms, for the treatment and prevention of recurrent
symptomatic VTE.[3]

Once-daily edoxaban also demonstrated superiority compared to
warfarin for the principal safety outcome of clinically relevant
bleeding (the composite of major or clinically relevant non-major
bleeding).[3]

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 treating and preventing deep vein thrombosis and pulmonary
embolism. Issued 26 August 2015. Available
at: http://www.nice.org.uk/guidance/TA354.
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) Büller H et al. Edoxaban versus warfarin for the treatment of symptomatic venous
thromboembolism. New England Journal of Medicine. 2013; 369(15): 1406-1415.
4) Cohen AT et al. Venous thromboembolism (VTE) in Europe: the number of VTE events and
associated morbidity and mortality. Thrombosis and Haemostasis. 2007; 98(4): 756-764.
5) Kearon C. Natural history of venous thromboembolism. Circulation 2003;107(23 suppl 1)
:I-22-30.
6) 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
.
7) NICE. Venous thromboembolic diseases: the management of venous thromboembolic diseases
and the role of thrombophilia testing. NICE clinical guideline 144. Issued June 2012.

Contact
Lydia Worms (Europe)
Daiichi Sankyo Europe GmbH
Edoxaban Comm. & 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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