<SEC-DOCUMENT>0001654954-20-000083.txt : 20200106
<SEC-HEADER>0001654954-20-000083.hdr.sgml : 20200106
<ACCEPTANCE-DATETIME>20200106064417
ACCESSION NUMBER:		0001654954-20-000083
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20200106
FILED AS OF DATE:		20200106
DATE AS OF CHANGE:		20200106

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:		20508018

	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>a8107y.htm
<DESCRIPTION>FARXIGA GRANTED FDA PRIORITY REVIEW FOR PATIENTS WITH HEART FAILURE WITH REDUCED EJECTION FRACTION
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<font style="font-family: Times New Roman; font-size: 13px">INDEX
TO EXHIBITS</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">1.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: rgb(0, 0, 0);">Farxiga</font><font style="color: #000000; font-size: 13px">&#xA0;granted FDA Priority Review
for patients</font><font style="color: #000000">&#xA0;</font><font style="color: #000000; font-size: 13px">with heart failure with reduced
ejection fraction</font></font></div>
</div>
</div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<font style="font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
6 January 2020 07:01&#xA0;GMT</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="font-style: italic; color: #000000">Farxiga</font><font style="color: #000000">&#xA0;granted FDA Priority Review for
patients</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">
with heart failure with reduced ejection fraction</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 today announced the US Food and Drug Administration
(FDA) has accepted a supplemental New Drug Application (sNDA) and
granted Priority Review for&#xA0;</font><font style="font-style: italic; color: #000000">Farxiga</font><font style="color: #000000">&#xA0;(dapagliflozin)&#xA0;to reduce the risk of
cardiovascular (CV) death or the worsening of heart failure (HF) in
adults with heart failure with reduced ejection fraction
(HFrEF)&#xA0;with and without type-2 diabetes
(T2D).</font><font style="font-style: italic; color: #000000">&#xA0;Farxiga</font><font style="color: #000000">&#xA0;is
a first-in-class, oral once-daily selective inhibitor of human
sodium-glucose co-transporter 2 (SGLT2).</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="color: #000000; font-family: Times New Roman; font-size: 13px">
The Prescription Drug User Fee Act date, the FDA action date for
this supplemental application, is scheduled for the second quarter
of 2020.</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 sNDA was based on results from&#xA0;the landmark Phase III
DAPA-HF trial&#xA0;published in September 2019
in&#xA0;</font><font style="font-style: italic; text-decoration: underline; color: #0000FF">The
New England Journal of Medicine</font><font style="color: #000000">,&#xA0;which&#xA0;showed&#xA0;</font><font style="font-style: italic; color: #000000">Farxiga</font><font style="color: #000000">&#xA0;on top of standard of care reduced the
incidence of the composite outcome of CV death or the worsening of
HF versus placebo.</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 this Priority Review shows its potential to
also impact millions of patients with heart failure. If
approved,&#xA0;</font><font style="font-style: italic; color: #000000">Farxiga</font><font style="color: #000000">&#xA0;will be the first and only medicine of its
kind indicated to treat patients with 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="text-decoration: underline; color: #0000FF">
In September 2019</font><font style="color: #000000">, the FDA
granted Fast Track designation for the development
of&#xA0;</font><font style="font-style: italic; color: #000000">Farxiga</font><font style="color: #000000">&#xA0;in HF.&#xA0;</font><font style="text-decoration: underline; color: #0000FF">In August
2019</font><font style="color: #000000">, the FDA also granted Fast
Track designation for the development of&#xA0;</font><font style="font-style: italic; color: #000000">Farxiga</font><font style="color: #000000">&#xA0;to delay the progression of renal failure
and prevent CV and renal death in patients with chronic kidney
disease, with and without 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="font-style: italic; color: #000000">
Farxiga</font><font style="color: #000000">&#xA0;is indicated as a
monotherapy and as part of combination therapies to improve
glycaemic control in adults with T2D.&#xA0;</font><font style="text-decoration: underline; color: #0000FF">In October
2019</font><font style="color: #000000">, the FDA also
approved&#xA0;</font><font style="font-style: italic; color: #000000">Farxiga</font><font style="color: #000000">&#xA0;to reduce the risk of hospitalisation for
heart failure in patients with T2D and established cardiovascular
disease or multiple CV risk factors.</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">
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 (at least 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 fatal 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; color: #000000; font-family: Times New Roman; font-size: 13px">
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 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
endpoint was time to the first occurrence of 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="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-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
Farxiga</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</font><font style="color: #000000">&#xA0;(dapagliflozin) is
a first-in-class, oral once-daily SGLT2 inhibitor indicated as both
monotherapy and as part of combination therapies 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>
<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">
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 and 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 comorbidities. 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>
<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">
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AstraZeneca&#xA0;(LSE/STO/NYSE: AZN)&#xA0;is a global, science-led
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development and commercialisation of prescription medicines,
primarily for the treatment of diseases in three therapy areas -
Oncology, Cardiovascular, Renal and Metabolism, and Respiratory.
AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide.&#xA0;Please
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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: #3C4242; font-size: 13px">1.&#xA0;&#xA0;&#xA0;</font><font style="color: #000000; font-size: 13px">Mayo
Clinic. Heart failure; 2017 [cited 2019 Aug 14]. Available from
URL:&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://www.mayoclinic.org/diseases-conditions/heart-failure/symptoms-causes/syc-20373142</font><font style="color: #000000; font-size: 13px">.</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: #3C4242">2.&#xA0;&#xA0;&#xA0;</font><font style="color: #000000">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: #3C4242">3.&#xA0;&#xA0;&#xA0;</font><font style="color: #000000">Travessa AMR, Menezes Falc&#xE3;o LF
de.&#xA0;Treatment of Heart Failure With Reduced Ejection
Fraction-Recent Developments.&#xA0;</font><font style="font-style: italic; color: #000000">Am J Ther</font><font style="color: #000000">. 2016;23(2):e531-49.
doi:10.1097/MJT.0000000000000406.</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: #3C4242; font-size: 13px">4.&#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:&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_heart_failure.htm</font><font style="color: #000000; font-size: 13px">&#xA0;</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: #3C4242; font-size: 13px">5.&#xA0;&#xA0;&#xA0;</font><font style="color: #000000; font-size: 13px">Mamas,
M. A., Sperrin, M., Watson, M. C., Coutts, A., Wilde, K., Burton,
C., ... Myint, P. K. (2017). Do patients have worse outcomes in
heart failure than in cancer? A primary care-based cohort study
with 10-year follow-up in Scotland.&#xA0;</font><font style="font-style: italic; color: #000000; font-size: 13px">European
Journal of Heart Failure</font><font style="color: #000000; font-size: 13px">, 19(9),
1095-1104.&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://doi.org/10.1002/ejhf.822</font><font style="color: #000000; font-size: 13px">&#xA0;</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: #3C4242">6.&#xA0;&#xA0;&#xA0;</font><font style="color: #000000">Azad, N., &amp; Lemay, G. (2014). Management of
chronic heart failure in the older
population.&#xA0;</font><font style="font-style: italic; color: #000000">Journal of Geriatric
Cardiology</font><font style="color: #000000">: JGC, 11(4),
329-37.</font></font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
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Adrian Kemp</font></div>
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Company Secretary</font></div>
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AstraZeneca PLC</font></div>
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SIGNATURES</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">AstraZeneca
PLC</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Date:
<font style="font-weight: bold; font-size: 13px">06 January
2020</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px">By: /s/
Adrian Kemp</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Name:
Adrian Kemp</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Title:
Company Secretary</font></div>
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