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2020-03-28

AstraZeneca: Farxiga reduced the incidence of heart failure worsening or cardiovascular death in a sub-analysis from landma...

New data showed consistent effect of Farxiga in patients with heart
failure with reduced ejection fraction, regardless of background
therapy

New data from a sub-analysis of the landmark Phase III DAPA-HF
(Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure)
trial showed that AstraZeneca's Farxiga (dapagliflozin) reduced the
incidence of the primary composite endpoint of heart failure (HF)
worsening or cardiovascular (CV) death compared to placebo, in
patients with heart failure with reduced ejection fraction (HFrEF),
irrespective of their background therapy (i.e. other medications for
heart failure).[1 ]

Farxiga was evaluated in patients who were receiving a broad range of
pharmacological treatments, device therapies and cardiac
resynchronisation therapy for HFrEF. A consistent reduction in the
primary outcome was observed across all these treatment subgroups.[1]

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said:
"These new data from the DAPA-HF trial further reinforce Farxiga's
clinical effects beyond diabetes. By reducing the risk of heart
failure worsening regardless of background therapy, Farxiga has the
potential to improve current standard of care and reduce the burden
of disease for heart failure patients across the globe."

The results were made available at the American College of
Cardiology's 69[th] Annual Scientific Session Together with World
Congress of Cardiology (ACC.20/WCC) and were published in the
European Heart Journal
(https://academic.oup.com/eurheartj/advance-article/doi/10.1093/eurheartj...).

Farxiga is indicated as a monotherapy and as part of combination
therapies to improve glycaemic control in adults with type-2 diabetes
(T2D). In the US it is also approved
(https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2...)
to reduce the risk of hospitalisation for HF in patients with T2D and
established CV disease or multiple CV risk factors.

In January 2020
(https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2...),
the US Food and Drug Administration (FDA) accepted a supplemental New
Drug Application (sNDA) and granted Priority Review for Farxiga to
reduce the risk of CV death or the worsening of HF in adults with
HFrEF with and without T2D. The Prescription Drug User Fee Act date,
the FDA action date for this supplemental application, is scheduled
for the second quarter of 2020.

Heart failure

HF is a life-threatening disease in which the heart cannot pump enough
blood around the body.[2] It affects approximately 64 million people
worldwide, at least half of whom have a reduced ejection fraction,
and is a chronic and degenerative disease where half of patients will
die within five years of diagnosis.[3,4] HF remains as fatal 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]

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 endpoint was time to the first occurrence of a
worsening heart failure event (hospitalisation or equivalent event;
i.e. an urgent heart failure visit), or cardiovascular death.

Farxiga

Farxiga is a first-in-class, oral once-daily SGLT2 inhibitor indicated
in adults for the treatment of insufficiently controlled T2D as both
monotherapy and as part of combination therapy as an adjunct to diet
and exercise to improve glycaemic control, with the additional
benefits of weight loss and blood-pressure reduction. In the DECLARE
CV outcomes trial in adults with T2D, Farxiga reduced the risk of the
composite endpoint of hospitalisation for HF or CV death versus
placebo, when both were added to standard of care.

In the DAPA-HF trial, Farxiga on top of standard of care reduced both
the incidence of cardiovascular death and the worsening of heart
failure in patients with HFrEF, with and without T2D. Farxiga is also
being investigated for patients with HF in the DELIVER (HFpEF) and
DETERMINE (HFrEF and HFpEF) trials, as well as patients with chronic
kidney disease (CKD) in the DAPA-CKD trial. 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.

AstraZeneca in CVRM

Cardiovascular, Renal and 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.

AstraZeneca

AstraZeneca (LSE/STO/NYSE: AZN) 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 and Metabolism, and Respiratory. Based in
Cambridge, UK, AstraZeneca operates in over 100 countries and its
innovative medicines are used by millions of patients worldwide.
Please visit astrazeneca.com (http://www.astrazeneca.com/) and follow
the Company on Twitter @AstraZeneca
(https://twitter.com/AstraZeneca).

Contacts

For details on how to contact the Investor Relations Team, please
click here
(https://www.astrazeneca.com/investor-relations.html#Contacts). For
Media contacts, click here
(https://www.astrazeneca.com/media-centre/contacts.html).

References

1. Docherty KF et al. 2020 Consistent Benefit of Dapagliflozin
According to Background Therapy in Patients with HFrEF: An Analysis
of the DAPA-HF Trial. Presented at the American College of
Cardiology's 69th Annual Scientific Session Together with World
Congress of Cardiology (ACC.20/WCC); 28 March - 30 March, Chicago.

2. Mayo Clinic. Heart failure; 2017 [cited 2020 Mar 24]. Available
from URL:
https://www.mayoclinic.org/diseases-conditions/heart-failure/symptoms-ca....

3. Travessa AMR, Menezes Falcão LF de. Treatment of Heart Failure
With Reduced Ejection Fraction-Recent Developments. Am J Ther 2016;
23(2):e531-49.

4. Mozaffarian D et al. Heart Disease and Stroke Statistics-2016
Update: A Report From the American Heart Association. Circulation
2016; 133(4):e38-360.

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. Management of chronic heart failure in the older
population. J Geriatr Cardiol 2014; 11(4):329-37.

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