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.
Detailed
results from Phase III DAPA-HF trial showed Farxiga significantly
reduced both the incidence of cardiovascular death and the
worsening of heart failure
02 September 2019 07:00 BST
Detailed results from Phase III
DAPA-HF trial showed Farxiga
significantly reduced both the incidence of cardiovascular
death
and the worsening of heart failure
DAPA-HF is the first outcomes trial with an SGLT2 inhibitor in
patients with
heart failure with reduced ejection fraction, with and without
type-2 diabetes
AstraZeneca today announced detailed results from
the landmark Phase III DAPA-HF
trial that showed Farxiga (dapagliflozin) on top of standard of care
reduced both the incidence of cardiovascular death and the
worsening of heart failure.
DAPA-HF is the first outcomes trial with an SGLT2 inhibitor
investigating the treatment of heart failure in patients with
reduced ejection fraction (HFrEF), with and without type-2 diabetes
(T2D). Farxiga is currently approved to treat patients with
T2D.
Topline results announced in August
2019 showed DAPA-HF met
the primary endpoint. The detailed results of the trial presented
at the ESC Congress 2019 in Paris, France,
showed Farxigareduced the composite of cardiovascular (CV) death
or worsening of heart failure by 26% (p<0.0001) and showed a
reduction in each of the individual components of the composite
endpoint.
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "Farxiga is well established in the treatment of
type-2 diabetes, and these exciting new findings offer clinically
meaningful insights into the potential of the medicine to reduce
the burden of heart failure in patients with and without type-2
diabetes. We are proud to be contributing to the scientific
body of evidence during the ESC Congress 2019."
John McMurray, MD, University of Glasgow, Cardiovascular Research
Centre, Institute of Cardiovascular and Medical Sciences, said: "We
are very pleased that Farxiga was so effective in our trial - it did all
the things we would like any drug to do in heart failure, which are
to improve symptoms, reduce hospital admissions and increase
survival. Even better, Farxiga was as effective in heart failure patients
without diabetes as in those with diabetes."
In analysing each of the components of the primary composite
endpoint, there was a 30% decrease (p<0.0001) in the risk of
experiencing a first episode of worsening heart failure and an 18%
decrease (p=0.0294) in the risk of dying from cardiovascular
causes. The effect of Farxiga on the primary composite endpoint was
generally consistent across the key subgroups
examined.
The trial results also showed a significant improvement in patient
reported outcomes measured by the Kansas City Cardiomyopathy
Questionnaire (KCCQ) total symptom score and a nominally
significant reduction in all-cause mortality by 17% (7.9 versus 9.5
patients with an event per 100 patient-years) in favour
of Farxiga.
The safety profile of Farxiga in the DAPA-HF trial was consistent with the
well-established safety profile of the medicine. The proportion of
patients with volume depletion (7.5% versus 6.8%) and renal adverse
events (6.5% vs 7.2%), which are commonly of concern when treating
heart failure, were comparable to placebo. Major hypoglycaemic
events (0.2% versus 0.2%) were rare in both treatment
groups.
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 an international, multi-centre, parallel group,
randomised, double-blinded trial in patients with heart failure and
reduced ejection fraction (LVEF ≤ 40%), with and without T2D,
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 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 T2D. 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 patients
with established CV disease, CV risk factors and varying stages of
renal disease, both with and without T2D, 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.
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. 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.
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
5. 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
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:
02 September
2019
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|