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2017-03-17

AstraZeneca: AstraZeneca receives Complete Response Letter from US FDA for ZS-9 (sodium zirconium cyclosilicate) for hyperkalaemia

AstraZeneca today announced that the US Food and Drug Administration
(FDA) has issued a Complete Response Letter (CRL) regarding the New
Drug Application (NDA) for ZS-9 (sodium zirconium cyclosilicate).
Sodium zirconium cyclosilicate is being developed for the treatment
of hyperkalaemia by ZS Pharma, a wholly-owned subsidiary of
AstraZeneca. Hyperkalaemia is characterised by high potassium levels
in the blood serum.

The CRL followed an inspection by the FDA of the ZS-9 manufacturing
facility. The CRL does not require the generation of any new clinical
data. AstraZeneca and ZS Pharma are committed to working with the FDA
to resolve the remaining matters under review as soon as possible.

AstraZeneca remains dedicated to developing and commercialising sodium
zirconium cyclosilicate for patients with hyperkalaemia, and is
confident in the profile of this potential medicine. As announced on
24 February 2017, sodium zirconium cyclosilicate received a positive
opinion by the Committee for Medicinal Products for Human Use in the
European Union. Any potential implications for ongoing regulatory
submissions are being assessed.

- ENDS -

NOTES TO EDITORS

References

1. Kosiborod M, Rasmussen HS, Lavin P, et al. "Effect of Sodium
Zirconium Cyclosilicate on Potassium Lowering for 28 Days Among
Outpatients With Hyperkalemia." JAMA. 2014.
doi:10.1001/jama.2014.15688.

About ZS-9 (sodium zirconium cyclosilicate)

ZS-9 (sodium zirconium cyclosilicate) is a powder for oral suspension.
The active ingredient is a non-absorbed zirconium silicate that
preferentially exchanges potassium for hydrogen and sodium. Clinical
trials indicate that it is stable at room temperature and has a rapid
onset of action. The FDA approval is supported by data from
double-blinded, placebo-controlled trials and an 11-month open label
extension study in adults with hyperkalaemia.

About Hyperkalaemia

Hyperkalaemia (high potassium levels in the blood serum) occurs in 23
to 47% of patients with chronic kidney disease and/or chronic heart
failure, and may lead to cardiac arrest and death (mortality up to
30% in patients with severe hyperkalaemia if not treated).1Treatment
with common heart medicines can also be responsible for increases in
hyperkalaemia.

About ZS Pharma

ZS Pharma, founded in 2008, was a publicly traded biopharmaceutical
company until it entered an agreement with AstraZeneca in November
2015 to be fully acquired. The transaction completed in December
2015. For more information, please visit: www.zspharma.com

About AstraZeneca in Chronic Kidney Disease

Chronic kidney disease (CKD) is a key strategic area of focus within
AstraZeneca's Cardiovascular and Metabolic Diseases (CVMD) therapy
area. By leveraging our expertise in diabetes and cardiovascular
disease, AstraZeneca is able to better understand the interplay of
these conditions and CKD to advance our scientific leadership in the
cardio-renal space. Through novel therapies and therapy combinations
that target both the complications of CKD and the underlying
mechanisms of CKD progression, we are building a portfolio to
aggressively prevent, treat, manage and modify this global public
health issue.

About AstraZeneca in Cardiovascular and Metabolic Diseases

Cardiovascular, renal and metabolic diseases are key areas of focus
for AstraZeneca as part of the company's strategy for achieving
scientific leadership and returning to growth. By collaborating
across therapeutic disciplines within the CVMD therapy area, we are
addressing the underlying disorders that drive CVMD risk, with the
goal of reducing morbidity, mortality and organ damage through
innovative therapies.

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 main therapy areas - Oncology, Cardiovascular & Metabolic
Diseases and Respiratory. The Company also is selectively active in
the areas of Autoimmunity, Neuroscience and Infection. AstraZeneca
operates in over 100 countries and its innovative medicines are used
by millions of patients worldwide. For more information, please visit
www.astrazeneca.com and follow us on Twitter @AstraZeneca.

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