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2019-08-20

AstraZeneca: 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 (http://www.astrazeneca.com/) and follow us on
Twitter @ (http://www.twitter.com/astrazeneca)AstraZeneca.
(https://clicktime.symantec.com/37Bg16U1oCzfevsztvEsc5x6H2?u=https%3A%2F%...)

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References

1. Mayo Clinic. Heart failure; 2017 [cited 2019 Aug 14]. Available
from URL:
https://www.mayoclinic.org/diseases-conditions/heart-failure/symptoms-ca....

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.

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