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 November
2018
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
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United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Farxiga
significantly reduced hospitalisation for
12 November 2018 07:00 GMT
Farxiga significantly reduced hospitalisation for
heart failure
or CV death in a broad patient population with type-2
diabetes
in the landmark DECLARE-TIMI 58 trial
Fewer MACE events observed with Farxiga vs. placebo,
but this finding did not reach statistical
significance
No imbalance in amputations, fractures, bladder cancer
or Fournier's gangrene with Farxiga vs. placebo
AstraZeneca
today announced positive full results from the DECLARE-TIMI 58
cardiovascular (CV) outcomes trial (CVOT) for Farxiga (dapagliflozin). The data
were presented as a late-breaking abstract (#19485) at the
American Heart Association (AHA) Scientific Sessions 2018 in
Chicago, Illinois, USA, and simultaneously published in
the New
England Journal of Medicine.1
Results
from DECLARE-TIMI 58, the largest SGLT2 inhibitor (SGLT2i) CVOT
conducted to date, including more than 17,000 patients across 33
countries, showed that Farxiga significantly reduced the
risk of hospitalisation for heart failure (hHF) or CV death
composite vs. placebo by 17% (4.9% vs. 5.8%; HR 0.83 [95% CI
0.73-0.95], p=0.005), one of the two primary efficacy endpoints.
The reduction in hHF or CV death was consistent across the entire
patient population, which included those with CV risk factors and
those with established CV disease.
Additionally,
there were fewer major adverse cardiovascular events (MACE)
observed with Farxigafor the other primary efficacy
endpoint, however this did not reach statistical significance (8.8%
for Farxiga vs.
9.4% for placebo; HR 0.93 [95% CI 0.84-1.03], p=0.17).
DECLARE-TIMI
58 also confirmed the well-established safety profile
for Farxiga, which met
the primary safety endpoint of non-inferiority vs. placebo,
demonstrating no increase in the composite of MACE, defined as CV
death, heart attack (myocardial infarction), or
stroke.
Further,
on other relevant safety measures, the trial showed no imbalance
with Farxiga vs.
placebo in amputations (1.4% vs. 1.3%), fractures (5.3% vs. 5.1%),
bladder cancer (0.3% vs. 0.5%) or Fournier's gangrene (1 case vs. 5
cases). The respective incidences of diabetic ketoacidosis (0.3%
vs. 0.1%) and genital infections (0.9% vs. 0.1%) were
rare.
Elisabeth
Björk, Vice President, Head of Cardiovascular, Renal and
Metabolism, Global Medicines Development, said: "These positive
results are clinically relevant to the 425 million people worldwide
living with diabetes, of whom those with type-2 diabetes have a
two-to-five times greater risk of heart failure along with an
increased risk of a heart attack or stroke. Heart failure survival
rates are only 50% after five years from diagnosis, which is why
these new findings are so important in broadening our understanding
of how to go beyond blood glucose so we may better address this
serious and often overlooked cardiovascular
complication."
Although
secondary endpoints were only nominally significant, the renal
composite endpoint showed that Farxiga reduced the rate of new or
worsening nephropathy1 by 24% vs.
placebo across the broad patient population studied (4.3% vs. 5.6%;
HR 0.76 [95% CI 0.67-0.87]), and there were fewer all-cause
mortality events with Farxiga vs. placebo (6.2% vs.
6.6%; HR 0.93 [95% CI 0.82-1.04]).
About DECLARE-TIMI 58
DECLARE
(Dapagliflozin Effect on Cardiovascular Events)-TIMI 58 is an
AstraZeneca-sponsored, randomised, double-blinded,
placebo-controlled, multicentre trial designed to evaluate the
effect of Farxiga compared with placebo on
CV outcomes in adults with T2D at risk of CV events, including
patients with multiple CV risk factors or established CV disease.
DECLARE included more than 17,000 patients across 882 sites in 33
countries and was independently run in collaboration with academic
investigators from the TIMI study group (Boston, USA) and the
Hadassah Hebrew University Medical Center (Jerusalem,
Israel).
About DapaCare
DECLARE
is part of the extensive DapaCare clinical programme
for Farxiga,
which will enrol patients in randomised clinical trials
including a wide range of mechanistic trials and is supported by a
multinational real-world evidence study (CVD-REAL). The DapaCare
clinical programme will generate data across a spectrum of people
with CV risk factors, established CV disease and varying stages of
renal disease, both with and without T2D. DECLARE is paving the way
for three Phase III trials: Dapa-HF, DELIVER and
Dapa-CKD. Farxiga is not indicated to reduce
the risk of CV events, CV death, or hHF, or the treatment of
CKD.
About Farxiga (dapagliflozin)
Farxiga is a first-in-class, oral once-daily selective
inhibitor of human sodium-glucose co-transporter 2 (SGLT2)
indicated as both monotherapy and as part of combination therapy to
improve glycaemic control, with the additional benefits of weight
loss and blood pressure reduction, as an adjunct to diet and
exercise in adults with T2D. Farxiga has a robust clinical
trial programme of more than 35 completed and ongoing Phase IIb/III
trials in over 35,000 patients, as well as more than 1.8 million
patient-years' experience.
About AstraZeneca in Cardiovascular, Renal & Metabolism
(CVRM)
Cardiovascular,
renal and metabolism together form one of AstraZeneca's main
therapy areas and 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
co-morbidities. Our 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, 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
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References
1 Wiviott S.D et al. 'Dapagliflozin and Cardiovascular Outcomes in
Type 2 Diabetes'. The New
England Journal of Medicine. DOI https://www.nejm.org/doi/full/10.1056/NEJMoa1812389
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:
12 November
2018
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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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