Blueprint
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 February
2019
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’s
PhIII THEMIS trial met primary endpoint
25 February 2019 07:00 GMT
Brilinta's Phase III THEMIS trial met primary endpoint
in
patients with established coronary artery disease and type-2
diabetes
Brilinta reduced cardiovascular events
in patients with no prior heart attack or
stroke
The Phase III THEMIS trial met its primary endpoint and
demonstrated that Brilinta (ticagrelor), taken in conjunction with
aspirin, showed a statistically-significant reduction in a
composite of major adverse cardiovascular events (MACE) compared to
aspirin alone.
THEMIS was conducted in over 19,000 patients with coronary artery
disease (CAD) and type-2 diabetes (T2D) with no prior heart attack
(myocardial infarction, MI) or stroke. Preliminary safety results
were consistent with the known profile of Brilinta. A full evaluation of the THEMIS data will be
presented at a forthcoming medical meeting.
Elisabeth Björk, Senior Vice President, Head of late
Cardiovascular, Renal and Metabolism, R&D BioPharmaceuticals,
said: "Approaches to help reduce cardiovascular morbidity further
in patients with coronary artery disease and type-2 diabetes are
urgently needed. The positive result from the THEMIS trial may
offer a potential benefit for this high-risk patient
population."
Deepak L. Bhatt, MD, MPH, THEMIS co-Chair and Executive Director of
Interventional Cardiovascular Programs at Brigham and Women's
Hospital and a Professor at Harvard Medical School said: "The
THEMIS trial is the largest randomised trial of patients with
type-2 diabetes performed to date and was designed to evaluate
whether more-intense antiplatelet therapy is a promising approach.
The results could help us refine our understanding of the role of
dual antiplatelet therapy in patients across the atherothrombotic
spectrum."
Gabriel Steg, MD, THEMIS co-Chair and Professor at Université
Paris-Diderot, Paris and Professor at the National Heart and Lung
Institute, Imperial College, London said: "Patients who have both
stable coronary artery disease and diabetes are a sizeable group
which remains at particularly high risk of major adverse cardiac
events. The optimal long-term antiplatelet therapy in that group is
not fully established. We look forward to presenting the full
results from the THEMIS trial later this year."
About THEMIS
THEMIS (Effect of Ticagrelor on Health Outcomes in DiabEtes
Mellitus Patients Intervention Study) is an AstraZeneca-sponsored,
multi-national, randomised, double-blinded trial in patients with
CAD and T2D with no prior myocardial infarction or stroke. THEMIS
was designed to test the hypothesis that Brilinta plus aspirin would reduce major adverse
cardiovascular events (MACE), a composite of CV death, myocardial
infarction or stroke, in patients with CAD and T2D with no prior
myocardial infarction or stroke, vs. aspirin alone. CAD was defined
as a prior percutaneous coronary intervention (PCI), bypass surgery
or at least a 50% narrowing of a coronary
artery.
The trial was initiated in early 2014, duration was event-driven
across 42 countries and more than 19,000 patients were randomised
in order to collect 1,385 independently-adjudicated primary
endpoint events.
About 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
events (myocardial infarction, stroke or CV death), in patients
with acute coronary syndrome (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.
About AstraZeneca in Cardiovascular, Renal & Metabolism
(CVRM)
Cardiovascular, renal and metabolism is one of AstraZeneca's main
therapy areas and platforms for future growth. By following the
science to understand more clearly the underlying links between the
heart, kidney 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.
Our ambition is to modify or halt the natural course of these
diseases and even regenerate organs and restore function, by
continuing to deliver transformative science that improves
treatment practices and CVRM health for millions of patients
worldwide.
About AstraZeneca
AstraZeneca 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. AstraZeneca operates in over 100
countries and its innovative medicines are used by millions of
patients worldwide. For more information, please
visit astrazeneca.com and
follow us on Twitter@AstraZeneca.
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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:
25 February
2019
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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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