FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of January
2020
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Brilinta met
primary endpoint in Phase III THALES trial in
stroke
27 January 2020 07:00 GMT
Brilinta met primary endpoint in Phase III THALES
trial in stroke
Brilinta reduced the risk of the composite of stroke and
death
after an acute ischaemic stroke or transient ischaemic
attack
High-level results from the Phase III THALES trial showed
AstraZeneca's Brilinta (ticagrelor) 90mg used twice daily and taken
with aspirin for 30 days, reached a statistically significant and
clinically meaningful reduction in the risk of the primary
composite endpoint of stroke and death, compared to aspirin
alone.
THALES was conducted in over 11,000 patients who had a minor acute
ischaemic stroke or high-risk transient ischaemic attack (TIA) in
the 24 hours prior to treatment initiation. The preliminary safety
findings in the THALES trial were consistent with the known profile
of Brilinta, with an increased bleeding rate in the treatment
arm.
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "Results of the Phase III THALES trial
showed Brilinta, in combination with aspirin, improved
outcomes in patients who had experienced a minor acute ischaemic
stroke or high-risk transient ischaemic attack. We look forward to
sharing the detailed results with health
authorities."
Dr. Clay Johnston, lead investigator for the THALES trial and Dean
of the Dell Medical School at The University of Texas at Austin,
US, said: "The risk of having a subsequent stroke is highest
in the first few days and weeks after a minor acute ischaemic
stroke or high-risk transient ischaemic attack. While an expected
increase in bleeding was observed, the findings from THALES showed
that Brilinta, in combination with aspirin, reduced the
risk of potentially devastating events in this crucial
time."
The full THALES trial results will be presented at a forthcoming
medical meeting.
Brilinta is approved in
more than 110 countries for the treatment of acute coronary
syndrome (ACS) and in more than 70 countries for the secondary
prevention of cardiovascular (CV) events among high-risk patients
who have experienced a heart attack.
Stroke
Stroke is the second leading cause of death worldwide, with 6.2
million stroke-related deaths in 2017, from which 2.7 million were
due to ischaemic stroke.1 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.2
THALES
THALES is an AstraZeneca-sponsored, randomised, placebo-controlled,
double-blinded, international, multicentre, event-driven trial
involving more than 11,000 patients to test the hypothesis
whether Brilinta and aspirin is superior to aspirin alone in
preventing the composite of stroke and death in patients with minor
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 treatments
were Brilinta 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.
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. Patients were followed for an
additional 30 days on standard of care.
Brilinta
Brilinta is an oral,
reversible, direct-acting P2Y12 receptor antagonist that works by
inhibiting platelet activation. Brilinta, together with aspirin, has been shown to
significantly reduce the risk of major adverse CV events
(myocardial infarction, stroke or CV death), in patients with ACS
or a history of myocardial infarction (MI).
Brilinta, 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.
AstraZeneca in CVRM
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.
AstraZeneca
AstraZeneca (LSE/STO/NYSE: AZN) 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 and Metabolism, and Respiratory.
AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide. Please
visit astrazeneca.com and
follow the Company on Twitter @AstraZeneca.
Media
Relations
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Gonzalo
Viña
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+44 203
749 5916
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Rob
Skelding
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Oncology
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+44 203
749 5821
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Rebecca
Einhorn
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Oncology
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+1 301
518 4122
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Matt
Kent
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BioPharmaceuticals
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+44 203
749 5906
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Angela
Fiorin
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BioPharmaceuticals
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+44
1223 344 690
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Jennifer
Hursit
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Other
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+44
203 749 5762
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Christina Malmberg
Hägerstrand
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Sweden
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+46 8 552 53 106
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Michele
Meixell
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US
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+1 302
885 2677
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Investor
Relations
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Thomas
Kudsk Larsen
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+44 203
749 5712
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Henry
Wheeler
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Oncology
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+44 203
749 5797
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Christer
Gruvris
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BioPharmaceuticals
(Cardiovascular,
Metabolism)
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+44 203
749 5711
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Nick
Stone
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BioPharmaceuticals
(Renal) Environmental, Social and Governance
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+44 203
749 5716
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Josie
Afolabi
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BioPharmaceuticals
(Respiratory)
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+44 203
749 5631
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Tom
Waldron
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Other
medicines
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+44
7385 033 717
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Marks
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Finance
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income
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US
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References
1. Roth GA et al. 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.
2. Khanevski AN, et al. Thirty-day recurrence after ischemic stroke
or TIA. Brain Behav 2018; 8(10):e01108.
Adrian Kemp
Company Secretary
AstraZeneca PLC
SIGNATURES
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.
Date:
27 January
2020
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
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