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2020-06-01

AstraZeneca: Brilinta approved in the US to reduce the risk of a first heart attack or stroke in high-risk patients with co...

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
(https://www.nejm.org/doi/full/10.1056/NEJMoa1908077) and The Lancet
(https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)31887-2/fulltext)
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
(https://www.astrazeneca.com/media-centre/press-releases/2020/brilinta-me...)
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 (http://www.astrazeneca.com/)
and follow the Company on Twitter @AstraZeneca
(https://twitter.com/AstraZeneca).

Contacts

For details on how to contact the Investor Relations Team, please
click here
(https://www.astrazeneca.com/investor-relations.html#Contacts). For
Media contacts, click here
(https://www.astrazeneca.com/media-centre/contacts.html).

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.

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