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 September
2019
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F X Form 40-F __
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1):
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ______
Indicate
by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information
to the Commission pursuant to Rule 12g3-2(b) under the Securities
Exchange Act of 1934.
Yes __
No X
If
“Yes” is marked, indicate below the file number
assigned to the Registrant in connection with Rule 12g3-2(b):
82-_____________
AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Brilinta
reduced the risk of cardiovascular events in patients with coronary
artery disease and type-2 diabetes in Phase III THEMIS
trial
02 September 2019 07:00 BST
Brilinta reduced the risk of cardiovascular events in
patients with
coronary artery disease and type-2 diabetes in Phase III THEMIS
trial
Additionally, Brilinta showed a more favourable clinical benefit in
a prespecified
sub-analysis of patients who had undergone a procedure to open a
coronary artery
AstraZeneca today announced detailed results from the positive
Phase III THEMIS trial which showed Brilinta (ticagrelor) plus aspirin reduced the
relative risk for the composite of cardiovascular (CV) death,
heart attack, or stroke by 10% compared with aspirin alone, a
statistically significant reduction.
The overall THEMIS trial population was patients with coronary
artery disease (CAD) and type-2 diabetes (T2D) with no prior heart
attack or stroke.
Additionally, in a clinically meaningful and prespecified
sub-analysis of patients who had previously undergone a
percutaneous coronary intervention (PCI), a procedure to open a
blocked or narrowed coronary artery, a 15% relative risk reduction
was observed for Brilinta plus aspirin for the composite of CV death,
heart attack, or stroke, compared with aspirin
alone.
The safety profile for Brilinta was consistent with the known profile of the
medicine with an increased risk of bleeding events observed in both
THEMIS and the THEMIS-PCI sub-analysis.
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "These positive results show
that Brilinta reduced the risk of cardiovascular events in
patients with coronary artery disease and type-2 diabetes, and we
hope this will make a difference because their risk of heart attack
or stroke is almost twice as high as it is among diabetes patients
without cardiovascular disease. Also, for the first time, these new
data identified an easily-recognisable sub-group of stable patients
who may benefit most from Brilinta - those with type-2 diabetes who have
undergone PCI."
Deepak L. Bhatt, MD, MPH, THEMIS Co-Chair and Executive Director of
Interventional Cardiovascular Programs at Brigham and Women's
Hospital, and Professor of Medicine at Harvard Medical School,
Boston, US said: "So far, treatment options have been limited for
patients with coronary artery disease and type-2 diabetes. The
results from THEMIS greatly advance our understanding of
cardiovascular risk reduction and refine our understanding of the
role of dual antiplatelet therapy in patients across the
cardiovascular spectrum."
Gabriel Steg, MD, THEMIS Co-Chair and Professor at Université
de Paris, said: "Patients with type-2 diabetes who had undergone a
percutaneous coronary intervention, face a similar risk of a
cardiovascular event as those who have had a heart attack. The PCI
population is a sizeable and easily identifiable group of patients
where we saw a more favourable net clinical benefit, that we hope
in the future will be considered for long-term therapy
with Brilinta and aspirin."
AstraZeneca will work with regulatory authorities to explore an
update to the Brilinta label based on these
results.
Results from THEMIS and THEMIS-PCI were presented on Sunday 1
September 2019 at the ESC Congress 2019 (the annual meeting of the
European Society of Cardiology) in Paris, France. The results for
the overall THEMIS trial were published simultaneously in
the New
England Journal of Medicine1 and
results from THEMIS-PCI were published in The Lancet.2
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, 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. More than 19,000
patients were randomised across 42 countries in Europe, Asia,
Africa, North and South America.
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).
About Brilinta
Brilinta 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 CVRM
Cardiovascular, Renal & 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 comorbidities. 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.
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, CVRM 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.
Media
Relations
|
|
|
Gonzalo
Viña
|
|
+44 203
749 5916
|
Rob
Skelding
|
Oncology
|
+44 203
749 5821
|
Rebecca
Einhorn
|
Oncology
|
+1 301
518 4122
|
Matt
Kent
|
BioPharmaceuticals
|
+44 203
749 5906
|
Jennifer
Hursit
|
Other
|
+44
203 749 5762
|
Christina Malmberg
Hägerstrand
|
Sweden
|
+46 8 552 53 106
|
Michele
Meixell
|
US
|
+1 302
885 2677
|
|
|
|
Investor
Relations
|
|
|
Thomas
Kudsk Larsen
|
|
+44 203
749 5712
|
Henry
Wheeler
|
Oncology
|
+44 203
749 5797
|
Christer
Gruvris
|
BioPharmaceuticals
(CV, metabolism)
|
+44 203
749 5711
|
Nick
Stone
|
BioPharmaceuticals
(respiratory, renal)
|
+44 203
749 5716
|
Josie
Afolabi
|
Other
medicines
|
+44 203
749 5631
|
Craig
Marks
|
Finance,
fixed income
|
+44
7881 615 764
|
Jennifer
Kretzmann
|
Corporate
access, retail investors
|
+44 203
749 5824
|
US
toll-free
|
|
+1 866
381 72 77
|
Adrian Kemp
Company Secretary
AstraZeneca PLC
References
1. Steg P.G et al. Ticagrelor in Patients with Stable Coronary
Disease and Diabetes. New England Journal of
Medicine.
2. 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. The Lancet.
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:
02 September
2019
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|