a5007o
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 June
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 approved in
the US to reduce the risk of a first heart attack or stroke in
high-risk patients with coronary artery disease
1 June 2020 07:00 BST
Brilinta approved in the US to reduce the risk of a
first heart
attack or stroke in high-risk patients with coronary artery
disease
New Brilinta indication expands treatment to high-risk coronary
patients without a history of stroke or heart attack
AstraZeneca's Brilinta (ticagrelor) has been approved in the US to
reduce the risk of a first heart attack or stroke in
high-risk patients with coronary artery disease (CAD),
the most common type of heart disease.
The approval by the US Food and Drug Administration (FDA) was based
on positive results from the Phase III THEMIS trial. The trial
showed a statistically significant reduction in the primary
composite endpoint of major adverse cardiovascular (CV) events at
36 months with aspirin plus Brilinta 60mg versus aspirin alone in patients with
CAD and type-2 diabetes (T2D) at high-risk of a first heart attack
or stroke.1 The
primary composite endpoint was driven by a reduction in heart
attack and stroke.
This is the first regulatory approval for aspirin
plus Brilinta dual antiplatelet therapy in patients who
have a high CV risk, but without a history of heart attack or
stroke.
Deepak L. Bhatt, MD, MPH, THEMIS trial Co-Chair, Executive Director
of Interventional Cardiovascular Programs at Brigham and Women's
Hospital, and Professor of Medicine at Harvard Medical School,
Boston, US said: "Coronary artery disease is a potentially
life-threatening condition that causes significant morbidity in
many people. The addition of ticagrelor to aspirin offers a new
therapeutic option to decrease the likelihood of both heart attack
and stroke, a significant advance in our ability to treat these
high-risk patients."
Gabriel Steg, MD, THEMIS trial Co-Chair and Professor at
Université de Paris, said: "THEMIS for ticagrelor was a large,
multi-national trial of more than 19,000 patients with coronary
artery disease and type-2 diabetes. Around one third of patients
with coronary artery disease have type-2 diabetes, putting them at
higher risk of heart attack or stroke, than patients without
diabetes. Today's approval brings new hope to patients at risk of
experiencing a first heart attack or stroke."
Ruud Dobber, Executive Vice President, BioPharmaceuticals Business
Unit, said: "Today's approval of Brilinta is important news for patients with coronary
artery disease who will now have a new therapy option to reduce the
risk of a first heart attack or stroke. This new indication is a
further testament to the overwhelming science
supporting Brilinta in the management of patients with coronary
artery disease at high risk for cardiovascular
events."
The THEMIS trial demonstrated the relative risk reduction of the
composite endpoint of heart attack, stroke and CV death by 10%
(absolute risk reduction; 0.8%, 7.7% vs 8.5%) with aspirin plus
long-term Brilinta compared to aspirin alone in patients who
had CAD and T2D without a history of heart attack or
stroke.1 While
this indication is not limited to this setting, the efficacy
of Brilinta was established in a population with T2D in
the THEMIS trial.2 The
safety profile for Brilinta was consistent with the known profile of the
medicine with an increased risk of bleeding events
observed.1
The data from the THEMIS trial and the THEMIS-PCI sub-analysis were
published in The
New England Journal of Medicine and The
Lancet respectively.
Regulatory submissions to expand the approved indication
for Brilinta based on the THEMIS trial are also under
regulatory review in the EU, Japan and China.
AstraZeneca also recently announced the high-level
results from the Phase III
THALES trial that showed aspirin plus Brilinta 90mg reduced the risk of the composite of
stroke and death at 30 days after an acute ischaemic stroke or
transient ischaemic attack, compared to aspirin
alone.
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 CV events among
high-risk patients who have experienced a prior myocardial
infarction.
CAD and T2D
CAD is the most common type of heart disease. Ischaemic heart
disease is the leading cause of healthy life years lost due to
disability in men and the second cause in women
worldwide.3,4 The
disease burden of atherosclerosis is significantly higher in
patients with CAD and T2D than in CAD patients without
T2D.5
THEMIS
THEMIS is an AstraZeneca-sponsored, multi-national, randomised,
double-blinded Phase III trial in patients with CAD and
T2D with no prior heart attack or stroke. More than 19,000 patients
were randomised across 42 countries in Europe, Asia, Africa, North
and South America. THEMIS was designed to test the hypothesis
that aspirin plus Brilinta 60mg twice daily would reduce MACE (major
adverse cardiac events), compared with aspirin alone. CAD was
defined as a percutaneous coronary intervention (PCI), bypass
surgery, or at least a 50% narrowing of a coronary artery.
Additionally, THEMIS-PCI is a clinically meaningful and
prespecified sub-analysis of patients (11,154 which is 58% of total
patients) who had previously undergone percutaneous coronary
intervention (PCI).
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 MACE defined as myocardial infarction (MI, heart
attack), stroke or CV death, in patients with ACS or a history of
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
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 & 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. Bhatt D.L et al. Ticagrelor in patients with diabetes and stable
coronary artery disease with a history of previous percutaneous
coronary intervention (THEMIS-PCI): A phase 3, placebo-controlled,
randomised trial. Lancet 2019; 394:1169-1180.
2. Brilinta (ticagrelor) prescribing information. AstraZeneca
Pharmaceuticals LP.
3. NIH National Heart, Lung, and Blood Institute. Ischemic heart
disease: Also known as coronary artery disease, coronary heart
disease, coronary microvascular disease [cited 2019 Feb 4].
Available from: URL: https://www.nhlbi.nih.gov/health-topics/ischemic-heart-disease.
4. Kyu HH et al. Global, regional, and national disability-adjusted
life-years (DALYs) for 359 diseases and injuries and healthy life
expectancy (HALE) for 195 countries and territories, 1990-2017: A
systematic analysis for the Global Burden of Disease Study
2017. Lancet 2018;
392(10159):1859-922.
5. Arnold S.V. et al. Clinical management of stable
coronary artery disease in patients with type 2 diabetes mellitus:
A scientific statement from the American Heart
Association. Circulation. 2020;
141:e779-e806.
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:
01 June 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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