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 November 2020
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
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United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Brilinta approved in the US in stroke
6 November 2020 07:00 GMT
Brilinta approved in the US to reduce the risk of
stroke in patients
with an acute ischaemic stroke or high-risk transient ischaemic
attack
New indication expands use of Brilinta beyond cardiovascular
disease
to patients with mild-to-moderate stroke
AstraZeneca's Brilinta (ticagrelor) has
been approved in the US to reduce the risk of stroke, a leading
cause of disability and death worldwide, in patients with acute
ischemic stroke (National Institutes of Health Stroke Scale score
≤5) or high-risk transient ischaemic attack
(TIA).
The approval by the US Food and Drug Administration
(FDA) was based on positive results from the THALES Phase III
trial that showed aspirin plus Brilinta 90mg significantly reduced the rate of the
composite of stroke and death compared to aspirin alone in patients
with acute ischaemic stroke or TIA.1 The
decision follows the Priority Review
designation granted by the
FDA in July 2020.
Dr. Clay Johnston, lead investigator for the THALES Phase III trial
and Dean of the Dell Medical School at The University of Texas in
Austin, US, said: "One in four patients who have had a stroke will
experience a second one, with the risk particularly high within the
first 30 days. The approval of Brilinta in combination with aspirin is an important
advancement to reduce the risk of recurrent stroke and much-awaited
good news for physicians and patients."
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "In the US, someone has a stroke every 40 seconds
and the impact on a person's life can be truly
devastating. Brilinta is a well-established medicine across
patients with coronary artery disease and with today's approval, we
can now expand its potential to patients with an acute ischaemic
stroke or transient ischemic attack."
The THALES trial demonstrated that Brilinta 90mg used twice daily and taken with daily
aspirin for 30 days, reduced the rate of the primary composite
endpoint of stroke and death by 17% (absolute risk reduction =
1.1%; hazard ratio 0.83; 95% confidence interval 0.71-0.96,
p=0.015), compared to aspirin alone in patients with an acute
ischemic stroke or TIA.1 This
was a statistically significant and clinically meaningful
reduction. The primary composite endpoint was driven by a reduction
in stroke.
The risk for severe bleeding events was 0.5% in patients receiving
aspirin plus Brilinta and 0.1% for aspirin alone. The results were
in line with the known safety profile of Brilinta.1 Full
data from the THALES Phase III trial can be found
in The
New England Journal of Medicine.
Regulatory submissions to expand the approved indication are also
under regulatory review in China and in the EU where the medicine's
name is Brilique.
Brilinta 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 patients who are at high-risk and have
experienced a heart attack. In May 2020, the US FDA approved
a new
indication for Brilinta to
include the reduction of the risk of a first heart attack or stroke
in high-risk patients with coronary artery
disease.
Stroke
An ischaemic stroke is caused by a blockage cutting off the blood
supply to a region of the brain. A transient ischaemic attack, is a
temporary blockage of the blood supply to a region of the brain,
resulting in symptoms only lasting for a short amount of time.
Stroke is a leading cause of disability and death
worldwide.2 In
the US, someone has a stroke every 40 seconds, and every four
minutes, someone dies of stroke.3 About
one in four strokes are recurrent, with the risk particularly high
within 30 days after the initial event and even higher when looking
at time periods closer to the initial event.4,5
THALES
THALES is an AstraZeneca-sponsored, randomised, placebo-controlled,
double-blinded, international, multicentre, event-driven Phase III
trial involving more than 11,000 patients from 28 countries. It
tested the hypothesis whether aspirin plus Brilinta 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 treated for 30 days. Study treatments
were Brilinta 180mg loading dose on day 1, 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, which includes fatal bleedings, intracranial
haemorrhage; and bleeding causing hemodynamic compromise requiring
intervention.
Brilinta
Brilinta (ticagrelor) 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 cardiovascular (CV)
events (heart attack, stroke or CV death), in patients with ACS or
a history of heart attack. In the US, Brilinta is also indicated for the reduction of the
risk of a first heart attack or stroke in high-risk patients with
coronary artery disease.
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 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.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: 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 & Metabolism, and
Respiratory & Immunology. Based in Cambridge, UK, 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.
Contacts
For details on how to contact the Investor Relations Team, please
click here.
For Media contacts, click here.
References
1. Brilinta (ticagrelor) prescribing information. AstraZeneca
Pharmaceuticals LP.
2. Johnston SC, Amarenco P, Denison H, et al. Ticagrelor and aspirin or aspirin alone in acute
ischemic stroke or TIA. N Engl J
Med 2020;
383:207-217.
3. Virani SS, Alonso A, Benjamin EJ et al. Heart disease and stroke
statistics-2020 update: a report from the American Heart
Association. Circulation. 2020;141(9):e139-e596.
4. Hankey GJ. Secondary stroke prevention. Lancet
Neurol 2014;
13(2):178-94.
5. Coull AJ, Lovett JK, and Rothwell PM. Population based
study of early risk of stroke after transient ischaemic attack or
minor stroke: implications for public education and organisation of
services. BMJ. 2004;328:326.
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:
06 November
2020
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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