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2020-01-06

AstraZeneca: Farxiga granted FDA Priority Review for patients with heart failure with reduced ejection fraction

AstraZeneca today announced the US Food and Drug Administration (FDA)
has accepted a supplemental New Drug Application (sNDA) and granted
Priority Review for Farxiga (dapagliflozin) to reduce the risk of
cardiovascular (CV) death or the worsening of heart failure (HF) in
adults with heart failure with reduced ejection fraction (HFrEF) with
and without type-2 diabetes (T2D). Farxiga is a first-in-class, oral
once-daily selective inhibitor of human sodium-glucose co-transporter
2 (SGLT2).

The Prescription Drug User Fee Act date, the FDA action date for this
supplemental application, is scheduled for the second quarter of
2020.

The sNDA was based on results from the landmark Phase III DAPA-HF
trial published in September 2019 in The New England Journal of
Medicine
(https://www.nejm.org/doi/full/10.1056/NEJMoa1911303?query=main_nav_lg),
which showed Farxiga on top of standard of care reduced the incidence
of the composite outcome of CV death or the worsening of HF versus
placebo.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said:
"Farxiga is well established in the treatment of type-2 diabetes and
this Priority Review shows its potential to also impact millions of
patients with heart failure. If approved, Farxiga will be the first
and only medicine of its kind indicated to treat patients with heart
failure."

In September 2019
(https://www.astrazeneca.com/media-centre/press-releases/2019/fda-grants-...),
the FDA granted Fast Track designation for the development of Farxiga
in HF. In August 2019
(https://www.astrazeneca.com/media-centre/press-releases/2019/fda-grants-...),
the FDA also granted Fast Track designation for the development of
Farxiga to delay the progression of renal failure and prevent CV and
renal death in patients with chronic kidney disease, with and without
T2D.

Farxiga is indicated as a monotherapy and as part of combination
therapies to improve glycaemic control in adults with T2D. In October
2019
(https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2...),
the FDA also approved Farxiga to reduce the risk of hospitalisation
for heart failure in patients with T2D and established cardiovascular
disease or multiple CV risk factors.

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 (at least 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 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 (dapagliflozin) is a first-in-class, oral once-daily SGLT2
inhibitor indicated as both monotherapy and as part of combination
therapies 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.

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. 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).

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
Angela Fiorin BioPharmaceuticals +44 1223 344 690
Jennifer Hursit Other +44 203 749 5762
Christina Sweden +46 8 552 53 106
Malmberg
Hägerstrand
Michele Meixell US +1 302 885 2677

Investor
Relations
Thomas Kudsk +44 203 749 5712
Larsen
Henry Wheeler Oncology +44 203 749 5797
Christer BioPharmaceuticals +44 203 749 5711
Gruvris (Cardiovascular, Metabolism)
Nick Stone BioPharmaceuticals (Renal) +44 203 749 5716
Environmental, Social and
Governance
Josie Afolabi BioPharmaceuticals +44 203 749 5631
(Respiratory) Other medicines
Craig Marks Finance Fixed income +44 7881 615 764
Jennifer Corporate access Retail +44 203 749 5824
Kretzmann investors
US toll-free +1 866 381 72 77

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. Travessa AMR, Menezes Falcão LF de. Treatment of Heart Failure
With Reduced Ejection Fraction-Recent Developments. Am J Ther.
2016;23(2):e531-49. doi:10.1097/MJT.0000000000000406.

4. 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

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.

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