AstraZeneca PLC US FDA issues CRL for ZS-9 in hyperkalaemia (7825Z)
March 17 2017 - 2:00AM
UK Regulatory
TIDMAZN
RNS Number : 7825Z
AstraZeneca PLC
17 March 2017
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
This information is provided by RNS
The company news service from the London Stock Exchange
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