TIDMAZN
RNS Number : 5004O
AstraZeneca PLC
01 June 2020
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
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
MSCFIFLERVILIII
(END) Dow Jones Newswires
June 01, 2020 02:00 ET (06:00 GMT)
Astrazeneca (LSE:AZN)
Historical Stock Chart
From Apr 2024 to May 2024
Astrazeneca (LSE:AZN)
Historical Stock Chart
From May 2023 to May 2024