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 August
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.
Farxiga
met primary endpoint in landmark Phase III
This announcement contains inside information
20 August 2019 07:00 BST
Farxiga met primary endpoint in landmark Phase III
DAPA-HF trial for the treatment of patients with heart
failure
DAPA-HF is the first heart failure outcomes trial with an SGLT2
inhibitor
in patients with and without type-2 diabetes
Farxiga significantly reduced the risk of cardiovascular death or
worsening
of heart failure when added to standard of care
AstraZeneca today announced positive results from the landmark
Phase III DAPA-HF trial which showed that Farxiga (dapagliflozin) met
the primary composite
endpoint with a statistically-significant and clinically-meaningful
reduction of cardiovascular death or the worsening of heart
failure (defined as
hospitalisation or an urgent heart failure visit), compared to
placebo. The trial was conducted in
patients with reduced
ejection fraction (HFrEF) on standard of care treatment, including
those with and without type-2 diabetes.
The safety profile of Farxiga in the DAPA-HF trial was consistent with the
well-established safety profile of the
medicine.
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "With the DAPA-HF
trial, Farxiga becomes
the first in its class to demonstrate efficacy and safety data for
the treatment of patients with heart failure, with and without
type-2 diabetes, on top of standard of care. Today, half of heart
failure patients will die within five years of diagnosis and it
remains one of the leading causes of hospitalisation. We look
forward to discussing the results of DAPA-HF with health
authorities as soon as possible."
John McMurray, MD, University of Glasgow, Cardiovascular Research
Centre, Institute of Cardiovascular and Medical Sciences said: "The
benefits of dapagliflozin in DAPA-HF are very impressive, with a
substantial reduction in the primary composite outcome of
cardiovascular death or hospital admission. We hope these exciting
new findings will ultimately help reduce the terrible burden of
disease caused by heart failure and help improve outcomes for our
patients."
DAPA-HF is the first heart failure outcomes trial with an SGLT2
inhibitor investigating the treatment of heart failure in adults
with HFrEF on top of standard of care (which includes
medicines such as angiotensin-converting enzyme [ACE] inhibitors,
angiotensin II receptor blockers [ARB], beta blockers,
mineralocorticoid-receptor antagonists [MRAs] and neprilysin
inhibitors), in patients with and without type-2
diabetes.
The full DAPA-HF trial results will be submitted for presentation
at a forthcoming medical meeting.
Farxiga is also being
studied in patients with heart failure with preserved ejection
fraction (HFpEF) in the DELIVER and DETERMINE (HFrEF and HFpEF)
trials.
About DAPA-HF
DAPA-HF (Dapagliflozin And Prevention of Adverse-outcomes in Heart
Failure) is the first heart failure trial with an SGLT2 inhibitor
and morbidity and mortality outcomes investigating the
treatment of heart failure on top of standard of care, in a
representative patient population (NYHA II to IV) with and
without type-2 diabetes. DAPA-HF is an international,
multi-centre, parallel group, randomised, double-blind trial in
patients with heart failure and reduced ejection fraction (LVEF
≤ 40%), with and without type-2 diabetes, designed to
evaluate the effect of Farxiga 10mg, compared with placebo, given once
daily in addition to standard of care. The primary composite
outcome was time to a worsening heart failure event
(hospitalisation or equivalent event; i.e. an urgent heart failure
visit), or cardiovascular death.
About heart failure
Heart failure (HF) is a life-threatening disease in which the heart
cannot pump enough blood around the body.1 It
affects approximately 64 million people worldwide (half of which
have a reduced ejection fraction) and is a chronic and degenerative
disease where half of patients will die within five years of
diagnosis.2,3,4 HF
remains as 'malignant' as some of the most common cancers in both
men (prostate and bladder cancers) and women (breast
cancers).5 It
is the leading cause of hospitalisation for those over the age of
65 and represents a significant clinical and economic
burden.6
About Farxiga
Farxiga is a
first-in-class, oral once-daily SGLT2 inhibitor 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 programme of clinical trials
that includes more than 35 completed and ongoing Phase IIb/III
trials in more than 35,000 patients, as well as more than 2.5
million patient-years' experience.
About the DapaCare Clinical Programme
AstraZeneca is taking a holistic, patient-centric approach to
disease management by addressing the underlying morbidity,
mortality and organ damage associated with cardiovascular (CV),
metabolic and renal diseases. Due to the interconnectivity of these
diseases, AstraZeneca has developed the DapaCare clinical programme
to explore the CV and renal profile of Farxiga in people with and without type-2 diabetes.
The clinical programme will enrol nearly 30,000 patients in
randomised clinical trials and is supported by a multinational
real-world evidence study. DapaCare will generate data across a
spectrum of people with established CV disease, CV risk factors and
varying stages of renal disease, both with and without type-2
diabetes, providing healthcare providers with evidence needed to
improve patient outcomes.
Farxiga is also being
developed for patients with heart failure in the DELIVER (HFpEF)
and DETERMINE (HFrEF and HFpEF) trials, in addition to chronic
kidney disease in the DAPA-CKD trial. DapaCare underscores our
commitment to following the science by pursuing a holistic patient
approach to address the multiple risk factors associated with CV,
renal and metabolic diseases.
About AstraZeneca in heart failure
AstraZeneca is committed to advancing science and clinical outcomes
with Farxiga in the treatment of people with HF. The
company's extensive clinical programme includes several global
Phase III trials (DAPA-HF, DELIVER and DETERMINE) focusing on
distinct and clinically important areas of HF research in order to
provide comprehensive clinical evidence around the disease and
address areas of high unmet need in HF. AstraZeneca is also
investing its efforts in compelling new science through early-stage
research of several potential medicines to address
HF.
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 co-morbidities. 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.
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Adrian Kemp
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AstraZeneca PLC
References
1. Mayo Clinic. Heart
failure; 2017 [cited 2019 Aug 14]. Available from
URL: https://www.mayoclinic.org/diseases-conditions/heart-failure/symptoms-causes/syc-20373142.
2. Vos T et al. Global, regional, and
national incidence, prevalence, and years lived with disability for
328 diseases and injuries for 195 countries, 1990-2016: A
systematic analysis for the Global Burden of Disease Study
2016. The Lancet 2017;
390(10100):1211-59.
3. Mozaffarian D et
al. Circulation.
2016 Jan 26;133(4):e38-360 and the CDC: https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_heart_failure.htm.
4. Mamas, M. A.,
Sperrin, M., Watson, M. C., Coutts, A., Wilde, K., Burton, C., ...
Myint, P. K. (2017). Do patients have worse outcomes in heart
failure than in cancer? A primary care-based cohort study with
10-year follow-up in Scotland. European
Journal of Heart Failure, 19(9),
1095-1104. https://doi.org/10.1002/ejhf.822
5.
Bhuiyan, Taslima, and Mathew S Maurer. "Heart Failure with
Preserved Ejection Fraction: Persistent Diagnosis, Therapeutic
Enigma." Current cardiovascular risk reports vol. 5,5 (2011):
440-449. doi:10.1007/s12170-011-0184-2
6. Azad, N., & Lemay, G. (2014).
Management of chronic heart failure in the older
population. Journal of Geriatric
Cardiology: JGC, 11(4),
329-37.
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:
20 August
2019
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|