Blueprint
FORM 6-K
SECURITIES AND
EXCHANGE COMMISSION
Washington, D.C.
20549
Report
of Foreign Issuer
Pursuant to Rule
13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For
the month of October 2016
Commission File
Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge CB2
0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1 A
accepts for review ZS-9 NDA for hyperkalaemia dated 18th October 2016
18 October 2016 [07:00]
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.
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.
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Adrian Kemp
Company Secretary, AstraZeneca PLC
SIGNATURES
Pursuant to the
requirements of the Securities Exchange Act of 1934, the Registrant
has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
AstraZeneca
PLC
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Date:
18 October
2016
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By:
/s/ Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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