<SEC-DOCUMENT>0001654954-20-007480.txt : 20200709
<SEC-HEADER>0001654954-20-007480.hdr.sgml : 20200709
<ACCEPTANCE-DATETIME>20200709074957
ACCESSION NUMBER:		0001654954-20-007480
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20200709
FILED AS OF DATE:		20200709
DATE AS OF CHANGE:		20200709

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:		201019541

	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>a5189s.htm
<DESCRIPTION>BRILINTA GRANTED US FDA PRIORITY REVIEW FOR STROKE
<TEXT>
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AstraZeneca PLC</font></div>
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Francis Crick Avenue</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Cambridge
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AstraZeneca PLC</font></div>
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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="font-size: 13px; font-family: Times New Roman">1.</font></div>
<div style="text-align: justify; display: table-cell"><font><font style="font-weight: bold; font-family: Times New Roman; font-size: 13px; font-style: italic;">
</font><font style="font-weight: bold; font-family: Times New Roman; font-size: 13px;"></font><font style="font-family: Times New Roman; font-size: 13px;"><font style="color: rgb(0, 0, 0);"><font style="font-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">Brilinta</font></font></font>
granted US FDA Priority Review for
stroke&#xA0;&#xA0;<br></font></font></div>
</div>
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<br></font></div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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&#xA0;</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
9 July 2020 07:00 BST</font></div>
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&#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">Brilinta</font><font style="color: #000000">&#xA0;granted FDA Priority Review for the
reduction of subsequent stroke</font></font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
in patients who had an acute ischemic stroke or transient ischemic
attack</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="color: #000000; font-weight: bold; font-style: italic; font-family: Times New Roman; font-size: 13px">
Brilinta in combination with aspirin could be the first
FDA-approved dual</font></div>
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<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
antiplatelet therapy to reduce the rate of stroke in these
high-risk patients</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-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">Brilinta</font><font style="color: #000000">&#xA0;(ticagrelor)&#xA0;for the reduction of
subsequent stroke in patients who experienced an acute ischemic
stroke or transient ischemic attack (TIA).</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="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 fourth 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>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
The sNDA was based on results from the Phase III THALES trial,
which showed aspirin plus&#xA0;</font><font style="font-style: italic; color: #000000">Brilinta</font><font style="color: #000000">&#xA0;90mg used twice daily for 30 days resulted
in a statistically significant and clinically meaningful reduction
in the risk of the primary composite endpoint of stroke and death,
compared to aspirin alone.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font><font style="color: #000000">&#xA0;</font><font style="font-size: 70%; vertical-align: top; color: #000000">&#xA0;</font><font style="color: #000000">The
results were in line with the known safety profile
of&#xA0;</font><font style="font-style: italic; color: #000000">Brilinta</font><font style="color: #000000">.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font></font></div>
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<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: "Patients who have had an acute ischaemic stroke or
transient ischemic attack are at high risk of experiencing a
subsequent stroke, which may be disabling or fatal. Today's
Priority Review reflects&#xA0;</font><font style="font-style: italic; color: #000000">Brilinta</font><font style="color: #000000">'s potential as a much-needed treatment option to
reduce the rate of subsequent stroke for these patients and we look
forward to working with the FDA to make&#xA0;</font><font style="font-style: italic; color: #000000">Brilinta</font><font style="color: #000000">&#xA0;available as soon as
possible."</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="color: #000000; font-family: Times New Roman; font-size: 13px">
The data from the THALES trial will be published in a peer reviewed
journal and presented at an forthcoming medical
congress.</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">
Brilinta</font><font style="color: #000000">&#xA0;is approved in
more than 110 countries for the prevention of atherothrombotic
events in adult patients with acute coronary syndrome (ACS) and in
more than 70 countries for the secondary prevention of
cardiovascular events among high-risk patients who have experienced
a heart attack. In May 2020, the FDA approved
a&#xA0;</font><font style="text-decoration: underline; color: #0000FF">label
update</font><font style="color: #000000">&#xA0;for&#xA0;</font><font style="font-style: italic; color: #000000">Brilinta</font><font style="color: #000000">&#xA0;in the US to include the reduction of the
risk of a first heart attack or stroke in high-risk patients with
coronary artery disease.</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">
Stroke</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">
Stroke is the second leading cause of death worldwide, with 6.2
million stroke-related deaths in 2017, of which 2.7 million were
due to ischaemic stroke.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2</font><font style="color: #000000">&#xA0;Patients
who experience an acute ischaemic stroke or TIA are at high risk of
developing subsequent ischaemic events, with particularly high risk
within 30 days after the initial event and the highest risk period
being the first 24 hours after the initial
event.</font><font style="font-size: 70%; vertical-align: top; color: #000000">3</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">
THALES</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">
THALES is an AstraZeneca sponsored, randomised, placebo-controlled,
double-blinded, international, multicentre, event-driven trial
involving more than 11,000 patients from 28 countries. It tested
the hypothesis whether aspirin plus&#xA0;</font><font style="font-style: italic; color: #000000">Brilinta</font><font style="color: #000000">&#xA0;is superior to aspirin alone in preventing
the composite of stroke and death in patients with
non-cardioembolic acute ischaemic stroke or high-risk TIA. Patients
were randomised within 24 hours of onset of acute ischaemic stroke
or high-risk TIA symptoms and followed-up for 30 days of treatment.
Trial&#xA0;treatments were&#xA0;</font><font style="font-style: italic; color: #000000">Brilinta</font><font style="color: #000000">&#xA0;180mg loading dose on day 1 as soon as
possible after randomisation, followed by 90mg twice daily on days
2-30, or matching placebo. All patients received open-label aspirin
300-325mg on day 1, followed by 75-100mg once daily on days
2-30.&#xA0;The primary efficacy outcome was the time to the
composite endpoint of stroke and death at 30 days. The primary
safety outcome is time to first severe bleeding event according to
the Global Utilization of Streptokinase and Tissue Plasminogen
Activator for Occluded Coronary Arteries (GUSTO) definition,
which&#xA0;includes fatal bleedings, intracranial haemorrhage; and
bleeding causing hemodynamic compromise requiring intervention.
Patients were followed for an additional 30 days on standard of
care.</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>
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<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
Brilinta</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">
Brilinta</font><font style="color: #000000">&#xA0;(ticagrelor) is
an oral, reversible, direct-acting P2Y12 receptor antagonist that
works by inhibiting platelet activation.&#xA0;</font><font style="font-style: italic; color: #000000">Brilinta</font><font style="color: #000000">, together with aspirin, has been shown to
significantly reduce the risk of major adverse cardiovascular
events (myocardial infarction, stroke or cardiovascular death), in
patients with ACS or a history of myocardial infarction (MI, heart
attack).</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-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">
Brilinta</font><font style="color: #000000">, co-administered with
aspirin, is indicated for the prevention of atherothrombotic events
in adult patients with ACS, or for patients with a history of MI
and a high risk of developing an atherothrombotic
event.</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">
AstraZeneca in CVRM</font></div>
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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>
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AstraZeneca</font></div>
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AstraZeneca&#xA0;(LSE/STO/NYSE: AZN)&#xA0;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, Cardiovascular, Renal &amp; Metabolism, and Respiratory
&amp; Immunology. Based in Cambridge, UK, AstraZeneca operates in
over 100 countries and its innovative medicines are used by
millions of patients worldwide. Please
visit&#xA0;</font><font style="text-decoration: underline; color: #0000FF">astrazeneca.com</font><font style="color: #000000">&#xA0;and
follow the Company on Twitter&#xA0;</font><font style="text-decoration: underline; color: #0000FF">@</font><font style="text-decoration: underline; color: #0000FF">AstraZeneca</font><font style="text-decoration: underline; color: #0000FF">.</font></font></div>
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Contacts</font></div>
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For details on how to contact the Investor Relations Team, please
click&#xA0;</font><font style="text-decoration: underline; color: #0000FF">here</font><font style="color: #000000">.
For Media contacts, click&#xA0;</font><font style="text-decoration: underline; color: #0000FF">here</font><font style="color: #000000">.</font></font></div>
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References</font></div>
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1.
AstraZeneca:&#xA0;https://otp.tools.investis.com/clients/uk/astrazeneca/rns/regulatory-story.aspx?cid=1343&amp;newsid=1361096].</font></div>
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2. Roth GA et al.&#xA0;Global, regional, and national
age-sex-specific mortality for 282 causes of death in 195 countries
and territories, 1980-2017: A systematic analysis for the Global
Burden of Disease Study 2017. The Lancet 2018;
392(10159):1736-88.</font></div>
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3. Khanevski AN, et al. Thirty-day recurrence after ischemic stroke
or TIA. Brain Behav 2018; 8(10):e01108.</font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
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>
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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>
<font><font style="font-family: Times New Roman; font-size: 13px">09 July
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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