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 March 2017
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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12g3-2(b): 82-_____________
This announcement contains inside information
17 March 2017 07:00 GMT
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.
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).1 Treatment 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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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.
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:
17 March 2017
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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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