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
Media Enquiries
Neil Burrows UK/Global +44 7842 350541
Vanessa Rhodes UK/Global +44 7880 400690
Karen Birmingham UK/Global +44 7818 524012
Jacob Lund Sweden +46 8 553 260 20
Michele Meixell US +1 302 885 2677
Investor Enquiries
UK
Thomas Kudsk Larsen +44 7818 524185
Nick Stone RIA, CVMD +44 7717 618834
Henry Wheeler Oncology +44 7788 354619
Craig Marks Finance +44 7881 615764
Christer Gruvris ING, Consensus Forecasts +44 7827 836825
US
Lindsey Trickett CVMD, Oncology +1 240 543 7970
Mitchell Chan Oncology +1 240 477 3771
Dial / Toll-Free +1 866 381 7277
Key: RIA – Respiratory, Inflammation and Autoimmunity, CVMD – Cardiovascular and
Metabolic Disease, ING – Infection, Neuroscience and Gastrointestinal
27 May 2016
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