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2016-10-18

AstraZeneca: FDA accepts for review New Drug Application for sodium zirconium cyclosilicate (ZS-9) for the treatment of hyperkalaemia

AstraZeneca today announced that the US Food and Drug Administration
(FDA) has accepted a complete re-submission of a New Drug Application
(NDA) for sodium zirconium cyclosilicate (ZS-9), a potential new
medicine for the treatment of hyperkalaemia (high potassium level in
the blood serum) by ZS Pharma, a wholly-owned subsidiary of
AstraZeneca. The FDA has indicated that this is a complete class 2
response.

Interactions with other health authorities in the European Union and
Australia are ongoing with decisions expected in the first half of
2017.

- ENDS -

NOTES TO EDITORS

About sodium zirconium cyclosilicate (ZS-9) for oral suspension

Sodium zirconium cyclosilicate (ZS-9) is an insoluble, non-absorbed
compound with a structure that was designed to preferentially capture
potassium ions. Sodium zirconium cyclosilicate has been studied in
three double-blind, placebo controlled trials and in one ongoing
12-month open label clinical trial in patients with hyperkalaemia
which represents over 1,600 patients treated. Sodium zirconium
cyclosilicate is an investigational medicine that is not currently
approved for any indication in any market.

About hyperkalaemia

Hyperkalaemia (potassium levels > 5.0 mEq/L in the blood serum)
commonly occurs in patients with advanced chronic kidney disease
and/or chronic heart failure, and may lead to cardiac arrest and
death. Treatment with common heart medicines (RAAS inhibitors) can
also be responsible for increases in hyperkalaemia. Current
therapeutic options are limited, leaving a high unmet medical need in
these patients.

About ZS Pharma
ZS Pharma was founded in 2008, became a public company in 2014 and, in
December 2015, joined the AstraZeneca Group. ZS Pharma is focused on
the development and commercialisation of highly selective,
non-absorbed drugs to treat renal, cardiovascular and metabolic
disorders. Additional information about ZS Pharma is available at
www.zspharma.com.

About AstraZeneca in Cardiovascular & Metabolic Disease (CVMD)

Cardiovascular, metabolic disease and chronic kidney disease are key
areas of focus for AstraZeneca as part of the company's strategy for
achieving scientific leadership and returning to growth. Our
patient-led strategy is focused on addressing the multiple risk
factors facing CVMD and CKD patients at different stages of their
disease, with the goal of reducing morbidity and mortality through
life changing medicines.

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.

CONTACTS

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