<SEC-DOCUMENT>0001654954-19-010242.txt : 20190903
<SEC-HEADER>0001654954-19-010242.hdr.sgml : 20190903
<ACCEPTANCE-DATETIME>20190903082911
ACCESSION NUMBER:		0001654954-19-010242
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20190903
FILED AS OF DATE:		20190903
DATE AS OF CHANGE:		20190903

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			ASTRAZENECA PLC
		CENTRAL INDEX KEY:			0000901832
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-11960
		FILM NUMBER:		191070922

	BUSINESS ADDRESS:	
		STREET 1:		1 FRANCIS CRICK AVENUE
		STREET 2:		CAMBRIDGE BIOMEDICAL CAMPUS
		CITY:			CAMBRIDGE
		STATE:			X0
		ZIP:			CB2 0AA
		BUSINESS PHONE:		011 44 20 7304 5000

	MAIL ADDRESS:	
		STREET 1:		1 FRANCIS CRICK AVENUE
		STREET 2:		CAMBRIDGE BIOMEDICAL CAMPUS
		CITY:			CAMBRIDGE
		STATE:			X0
		ZIP:			CB2 0AA

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	ZENECA GROUP PLC
		DATE OF NAME CHANGE:	19930422
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>a8036k.htm
<DESCRIPTION>DETAILED RESULTS FROM PHASE III DAPA-HF TRIAL SHOWED FARXIGA SIGNIFICANTLY REDUCED BOTH THE INCIDENCE OF CARDIOVASCULAR DEATH AND THE WORSENING OF HEART FAILURE
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TO EXHIBITS</font></div>
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<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">1.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">Detailed
results from Phase III DAPA-HF trial showed Farxiga significantly
reduced both the incidence of cardiovascular death and the
worsening of heart failure</font></div>
</div>
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&#xA0;</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
02 September 2019 07:00 BST</font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
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<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
<font style="color: #000000">Detailed results from Phase III
DAPA-HF trial showed&#xA0;</font><font style="font-style: italic; color: #000000">Farxiga</font></font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
significantly reduced both the incidence of cardiovascular
death</font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
and the worsening of heart failure</font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
DAPA-HF is the first outcomes trial with an SGLT2 inhibitor in
patients with</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
heart failure with reduced ejection fraction, with and without
type-2 diabetes</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
AstraZeneca&#xA0;today announced detailed results from
the&#xA0;landmark&#xA0;Phase III&#xA0;DAPA-HF
trial&#xA0;that&#xA0;showed&#xA0;</font><font style="font-style: italic; color: #000000">Farxiga</font><font style="color: #000000">&#xA0;(dapagliflozin) on top of standard of care
reduced both the&#xA0;incidence of cardiovascular death and the
worsening of heart failure.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
DAPA-HF is the first outcomes trial with an SGLT2 inhibitor
investigating the treatment of heart failure in patients with
reduced ejection fraction (HFrEF), with and without type-2 diabetes
(T2D).&#xA0;</font><font style="font-style: italic; color: #000000">Farxiga</font><font style="color: #000000">&#xA0;is currently approved to treat patients with
T2D.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Topline results announced in&#xA0;</font><font style="text-decoration: underline; color: #0000FF">August
2019</font><font style="color: #000000">&#xA0;showed DAPA-HF met
the primary endpoint. The detailed results of the trial presented
at the ESC Congress 2019 in Paris, France,
showed&#xA0;</font><font style="font-style: italic; color: #000000">Farxiga</font><font style="color: #000000">reduced the composite of cardiovascular (CV) death
or worsening of heart failure by 26% (p&lt;0.0001) and showed a
reduction in each of the individual components of the composite
endpoint.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&amp;D, said: "</font><font style="font-style: italic; color: #000000">Farxiga</font><font style="color: #000000">&#xA0;is well established in the treatment of
type-2 diabetes, and these exciting new findings offer clinically
meaningful insights into the potential of the medicine to reduce
the burden of heart failure in patients with and without type-2
diabetes. We&#xA0;are proud to be contributing to the scientific
body of evidence during the ESC Congress 2019."</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
John McMurray, MD, University of Glasgow, Cardiovascular Research
Centre, Institute of Cardiovascular and Medical Sciences, said: "We
are very pleased that&#xA0;</font><font style="font-style: italic; color: #000000">Farxiga</font><font style="color: #000000">&#xA0;was so effective in our trial - it did all
the things we would like any drug to do in heart failure, which are
to improve symptoms, reduce hospital admissions and increase
survival. Even better,&#xA0;</font><font style="font-style: italic; color: #000000">Farxiga</font><font style="color: #000000">&#xA0;was as effective in heart failure patients
without diabetes as in those with diabetes."</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
In analysing each of the components of the primary composite
endpoint, there was a 30% decrease (p&lt;0.0001) in the risk of
experiencing a first episode of worsening heart failure and an 18%
decrease (p=0.0294) in the risk of dying from cardiovascular
causes. The effect of&#xA0;</font><font style="font-style: italic; color: #000000">Farxiga</font><font style="color: #000000">&#xA0;on the primary composite endpoint was
generally consistent across the key subgroups
examined.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
The trial results also showed a significant improvement in patient
reported outcomes measured by the Kansas City Cardiomyopathy
Questionnaire (KCCQ) total symptom score and a nominally
significant reduction in all-cause mortality by 17% (7.9 versus 9.5
patients with an event per 100 patient-years) in favour
of&#xA0;</font><font style="font-style: italic; color: #000000">Farxiga</font><font style="color: #000000">.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
The safety profile of&#xA0;</font><font style="font-style: italic; color: #000000">Farxiga</font><font style="color: #000000">&#xA0;in the DAPA-HF trial was consistent with the
well-established safety profile of the medicine. The proportion of
patients with volume depletion (7.5% versus 6.8%) and renal adverse
events (6.5% vs 7.2%), which are commonly of concern when treating
heart failure, were comparable to placebo. Major hypoglycaemic
events (0.2% versus 0.2%) were rare in both treatment
groups.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">
Farxiga&#xA0;</font><font style="color: #000000">is also being
studied in patients with heart failure with preserved ejection
fraction (HFpEF) in the DELIVER and DETERMINE (HFrEF and HFpEF)
trials.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
About DAPA-HF</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
DAPA-HF (Dapagliflozin And Prevention of Adverse-outcomes in Heart
Failure) is an&#xA0;international, multi-centre, parallel group,
randomised, double-blinded trial in patients with heart failure and
reduced ejection fraction (LVEF &#x2264; 40%), with and without T2D,
designed to evaluate the effect of&#xA0;</font><font style="font-style: italic; color: #000000">Farxiga</font><font style="color: #000000">&#xA0;10mg, compared with placebo, given once
daily in addition to standard of care. The primary composite
outcome was time to a worsening heart failure event
(hospitalisation or equivalent event; i.e. an urgent heart failure
visit), or cardiovascular death.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
About heart failure</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Heart failure (HF) is a life-threatening disease in which the heart
cannot pump enough blood around the body.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font><font style="color: #000000">&#xA0;It
affects approximately 64 million people worldwide (half of which
have a reduced ejection fraction) and is a chronic and degenerative
disease where half of patients will die within five years of
diagnosis.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2,3,4</font><font style="color: #000000">&#xA0;HF
remains as 'malignant' as some of the most common cancers in both
men (prostate and bladder cancers) and women (breast
cancers).</font><font style="font-size: 70%; vertical-align: top; color: #000000">5</font><font style="color: #000000">&#xA0;It
is the leading cause of hospitalisation for those over the age of
65 and represents a significant clinical and economic
burden.</font><font style="font-size: 70%; vertical-align: top; color: #000000">6</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
<font style="color: #000000">About&#xA0;</font><font style="font-style: italic; color: #000000">Farxiga</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">
Farxiga</font><font style="color: #000000">&#xA0;is a
first-in-class, oral once-daily SGLT2 inhibitor indicated as both
monotherapy and as part of combination therapy to improve glycaemic
control, with the additional benefits of weight loss and
blood-pressure reduction, as an adjunct to diet and exercise in
adults with T2D.&#xA0;</font><font style="font-style: italic; color: #000000">Farxiga</font><font style="color: #000000">&#xA0;has a robust programme of clinical trials
that includes more than 35 completed and ongoing Phase IIb/III
trials in more than 35,000 patients, as well as more than 2.5
million patient-years' experience.</font></font></div>
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About the DapaCare clinical programme</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
AstraZeneca is taking a holistic, patient-centric approach to
disease management by addressing the underlying morbidity,
mortality and organ damage associated with CV, metabolic and renal
diseases. Due to the interconnectivity of these diseases,
AstraZeneca has developed the DapaCare clinical programme to
explore the CV and renal profile of&#xA0;</font><font style="font-style: italic; color: #000000">Farxiga</font><font style="color: #000000">&#xA0;in people with and without T2D. The clinical
programme will enrol nearly 30,000 patients in randomised clinical
trials and is supported by a multinational real-world evidence
study. DapaCare will generate data across a spectrum of patients
with established CV disease, CV risk factors and varying stages of
renal disease, both with and without T2D, providing healthcare
providers with evidence needed to improve patient
outcomes.</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">
Farxiga&#xA0;</font><font style="color: #000000">is also being
developed for patients with heart failure in the DELIVER (HFpEF)
and DETERMINE (HFrEF and HFpEF) trials, in addition to chronic
kidney disease in the DAPA-CKD trial. DapaCare underscores our
commitment to following the science by pursuing a holistic patient
approach to address the multiple risk factors associated with CV,
renal and metabolic diseases.</font></font></div>
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&#xA0;</font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
About AstraZeneca in heart failure</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
AstraZeneca is committed to advancing science and clinical outcomes
with&#xA0;</font><font style="font-style: italic; color: #000000">Farxiga</font><font style="color: #000000">&#xA0;in the treatment of people with HF. The
company's extensive clinical programme includes several global
Phase III trials (DAPA-HF, DELIVER and DETERMINE) focusing on
distinct and clinically important areas of HF research in order to
provide comprehensive clinical evidence around the disease and
address areas of high unmet need in HF. AstraZeneca is also
investing its efforts in compelling new science through early-stage
research of several potential medicines to address
HF.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
About AstraZeneca in CVRM</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
Cardiovascular, Renal &amp; Metabolism (CVRM) together forms one of
AstraZeneca's three therapy areas and is a key growth driver for
the Company. By following the science to understand more clearly
the underlying links between the heart, kidneys and pancreas,
AstraZeneca is investing in a portfolio of medicines to protect
organs and improve outcomes by slowing disease progression,
reducing risks and tackling co-morbidities. The Company's ambition
is to modify or halt the natural course of CVRM diseases and
potentially regenerate organs and restore function, by continuing
to deliver transformative science that improves treatment practices
and cardiovascular health for millions of patients
worldwide.</font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
About AstraZeneca</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
AstraZeneca is a global, science-led biopharmaceutical company that
focuses on the discovery, development and commercialisation of
prescription medicines, primarily for the treatment of diseases in
three therapy areas - Oncology, CVRM, and Respiratory. AstraZeneca
operates in over 100 countries and its innovative medicines are
used by millions of patients worldwide.&#xA0;For more information,
please visit</font><font style="text-decoration: underline; color: #0000FF">&#xA0;</font><font style="text-decoration: underline; color: #0000FF">astrazeneca.com</font><font style="color: #000000">&#xA0;and
follow us on Twitter&#xA0;</font><font style="text-decoration: underline; color: #0000FF">@</font><font style="text-decoration: underline; color: #0000FF">AstraZeneca.</font></font></div>
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References</font></div>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px;">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">1.&#xA0;&#xA0; Mayo Clinic. Heart
failure; 2017 [cited 2019 Aug 14]. Available from URL:
https://www.mayoclinic.org/diseases-conditions/heart-failure/symptoms-causes/syc-20373142.</font>
<font style="color: #000000"><br></font></font></div>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px;">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">2.&#xA0;&#xA0; Vos T et al. Global, regional, and
national incidence, prevalence, and years lived with disability for
328 diseases and injuries for 195 countries, 1990-2016: A
systematic analysis for the Global Burden of Disease Study
2016.&#xA0;</font><font style="font-style: italic; color: #000000">The Lancet</font><font style="color: #000000">&#xA0;2017;
390(10100):1211-59.</font></font></div>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px;">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">3.&#xA0;&#xA0;&#xA0;</font><font style="color: #000000; font-size: 13px">Mozaffarian D et
al.&#xA0;</font><font style="font-style: italic; color: #000000; font-size: 13px">Circulation</font><font style="color: #000000; font-size: 13px">.
2016 Jan 26;133(4):e38-360 and the CDC:
https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_heart_</font><font style="color: #000000; font-size: 13px">failure.htm</font></font></div>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px;">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">4.&#xA0;&#xA0;
Bhuiyan, Taslima, and Mathew S Maurer. "Heart Failure with
Preserved Ejection Fraction: Persistent Diagnosis, Therapeutic
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Scotland.&#xA0;</font><font style="font-style: italic; color: #000000">European Journal of Heart
Failure</font><font style="color: #000000">, 19(9), 1095-1104.
https://doi.org/10.1002/ejhf.822</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">6.&#xA0;&#xA0; Azad, N., &amp; Lemay, G. (2014).
Management of chronic heart failure in the older
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<font style="font-family: Times New Roman; font-size: 13px">AstraZeneca
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<font style="font-family: Times New Roman; font-size: 13px">Date:
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