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2019-08-27

AstraZeneca: FDA grants Fast Track designation for Farxiga in chronic kidney disease

AstraZeneca today announced that the US Food and Drug Administration
(FDA) has granted Fast Track designation for the development of
Farxiga (dapagliflozin) to delay the progression of renal failure and
prevent cardiovascular (CV) and renal death in patients with chronic
kidney disease (CKD).

The FDA's Fast Track programme is designed to accelerate the
development and review of new medicines for the treatment of serious
conditions where there is an unmet treatment need. The designation
was assigned to CKD patients with and without type-2 diabetes (T2D).

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said:
"Chronic kidney disease affects an estimated 37 million people in the
US,[ ]and is often associated with an increased risk of heart disease
and stroke. This Fast Track designation is an important step towards
more quickly addressing unmet treatment needs in chronic kidney
disease, and we will work closely with the FDA to explore the
potential for Farxiga to improve outcomes for these patients."

The Phase III DAPA-CKD clinical trial is currently underway to
evaluate the effect of Farxiga on renal outcomes and CV mortality in
patients with CKD with and without T2D versus placebo, on top of
standard of care.

About chronic kidney disease

CKD is a serious, progressive condition defined by decreased kidney
function (shown by reduced estimated glomerular filtration rate
(eGFR), markers of kidney damage, or both, for at least three
months.[1] The most common causes of CKD are diabetes and
hypertension.[2] CKD affects an estimated 200 million adults
globally.[3]

CKD is associated with increased risk of therapy-resistant
hypertension,[4] chronic fluid overload,[5] heart failure,[6] and CV
and all-cause death.[7,2] In its most severe form, known as end-stage
renal disease (ESRD), kidney damage and deterioration of kidney
function have progressed to the stage where dialysis or kidney
transplantation are required.[8] The majority of patients with ESRD
will die from CV causes.[9]

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 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.

In addition to the DAPA-CKD trial, Farxiga is also being developed for
patients with heart failure in the DAPA-HF (HFrEF), DELIVER (HFpEF)
and DETERMINE (HFrEF and HFpEF) trials. 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 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%...)

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 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 +44 203 749 5716
(respiratory, renal)
Josie Afolabi Other medicines +44 203 749 5631
Craig Marks Finance, fixed income +44 7881 615 764
Jennifer Corporate access, +44 203 749 5824
Kretzmann retail investors
US toll-free +1 866 381 72 77

References

1. Mallappallil, M., Friedman, E. A., Delano, B. G., McFarlane, S.
I., & Salifu, M. O. (2014). Chronic kidney disease in the elderly:
evaluation and management. Clinical practice (London, England),
11(5), 525-535. doi:10.2217/cpr.14.46.

2. Webster AC, Nagler EV, Morton RL, Masson P. Chronic Kidney
Disease. Lancet. 2017;389(10075):1238-52.

3. Ojo A. Addressing the global burden of chronic kidney disease
through clinical and translational research. Trans Am Clin Climatol
Assoc. 2014;125:229-43; discussion 243-6.

4. Tanner RM, Calhoun DA, Bell EK, Bowling CB, Gutierrez OM, Irvin
MR, et al. Prevalence of apparent treatment-resistant hypertension
among individuals with CKD. Clin J Am Soc Nephrol. 2013;8(9):1583-90.

5. Agarwal R. Resistant hypertension and the neglected
antihypertensive: sodium restriction. Nephrol Dial Transplant.
2012;27(11):4041-5.

6. Dhingra R, Gaziano JM, Djousse L. Chronic kidney disease and the
risk of heart failure in men. Circ Heart Fail. 2011;4(2):138-44.

7. Muntner P, He J, Hamm L, Loria C, Whelton PK. Renal Insufficiency
and Subsequent Death Resulting from Cardiovascular Disease in the
United States. Journal of the American Society of Nephrology.
2002;13(3):745.

8. Centers for Disease Control and Prevention. Chronic Kidney Disease
in the United States, 2019; [cited 2019 Aug 24]. Available from URL:
https://www.cdc.gov/kidneydisease/publications-resources/2019-national-f....

9. Thompson S, James M, Wiebe N, Hemmelgarn B, Manns B, Klarenbach S
and Tonelli M. Cause of Death in Patients with Reduced Kidney
Function. Journal of the American Society of Nephrology. 2015, 26
(10) 2504-2511; DOI: https://doi.org/10.1681/ASN.2014070714.

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