AstraZeneca PLC AstraZeneca receives CRL from US FDA for ZS-9 (4788Z)
May 27 2016 - 1:00AM
UK Regulatory
TIDMAZN
RNS Number : 4788Z
AstraZeneca PLC
27 May 2016
AstraZeneca RECEIVES COMPLETE RESPONSE LETTER FROM US FDA FOR
SODIUM ZIRCONIUM CYCLOSILICATE (Zs-9) FOR ORAL SUSPENSION for
treatment of Hyperkalaemia
27 May 2016
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 sodium zirconium
cyclosilicate (ZS-9), the investigational medicine being developed
for the treatment of hyperkalaemia (high potassium level in the
blood serum) by ZS Pharma, a wholly-owned subsidiary of
AstraZeneca.
The CRL refers to observations arising from a pre-approval
manufacturing inspection. The FDA also acknowledged receipt of
recently-submitted data which it has yet to review. The CRL does
not require the generation of new clinical data. AstraZeneca and ZS
Pharma are evaluating the content of the CRL and will work closely
with the FDA to determine the appropriate next steps for the
NDA.
AstraZeneca remains committed to the development of sodium
zirconium cyclosilicate as a treatment option for patients with
hyperkalaemia. Interactions are ongoing with other health
authorities in the European Union and Australia, where sodium
zirconium cyclosilicate is currently under separate regulatory
review.
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 trap potassium ions. The unique potassium
selectivity of sodium zirconium cyclosilicate enables high in-vitro
binding capacity for potassium ions even in the presence of other
competing 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 hyperkalemia which
represents over 1,600 patients treated. Sodium zirconium
cyclosilicate is an investigational product that is not currently
approved for any indication in any market.
About Hyperkalaemia
Hyperkalaemia (high potassium levels > 5.0 mEq/L in the blood
serum) occurs in 23-47% of patients with advanced chronic kidney
disease and/or chronic heart failure, and may lead to cardiac
arrest and death (mortality of up to 30% in patients with severe
hyperkalaemia if not treated rapidly). Treatment with common heart
medicines (RAAS inhibitors) can also be responsible for increases
in hyperkalaemia. Current therapeutic options are limited, leaving
high unmet medical need.
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, liver
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, innovation-driven biopharmaceutical
business that focuses on the discovery, development and
commercialisation of prescription medicines, primarily for the
treatment of diseases in three main therapy areas - respiratory,
inflammation, autoimmune disease (RIA), cardiovascular and
metabolic disease (CVMD) and oncology - as well as in infection and
neuroscience. 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
CONTACTS
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US
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Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD -
Cardiovascular and Metabolic Disease, ING - Infection, Neuroscience
and Gastrointestinal
27 May 2016
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