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
 
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F X Form 40-F __
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ______
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes __ No X
If “Yes” is marked, indicate below the file number assigned to the Registrant in connection with Rule 12g3-2(b): 82-_____________
 
 
 
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.
 
 
Media Enquiries
 
 
 
Neil Burrows
 
UK/Global
 
+44 203 749 5637
 
Vanessa Rhodes
 
UK/Global
 
+44 203 749 5736
 
Karen Birmingham
 
UK/Global
 
+44 203 749 5634
 
Rob Skelding
 
UK/Global
 
+44 203 749 5821
 
Jacob Lund
 
Sweden
 
+46 8 553 260 20
 
Michele Meixell
 
US
 
+1 302 885 2677
 
 
 
 
Investor Relations
 
 
 
Thomas Kudsk Larsen
 
 
 
+44 203 749 5712
 
Craig Marks
 
Finance, Fixed Income, M&A
 
+44 7881 615 764
 
Henry Wheeler
 
Oncology
 
+44 203 749 5797
 
Mitchell Chan
 
Oncology
 
+1 240 477 3771
 
Lindsey Trickett
 
Cardiovascular & Metabolic Diseases
 
+1 240 543 7970
 
Nick Stone
 
Respiratory
 
+44 203 749 5716
 
Christer Gruvris
Autoimmunity, neuroscience &
infection
+44 203 749 5711
 
US toll free
 
 
+1 866 381 7277
 
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
 
 Date: 18 October 2016
By: /s/ Adrian Kemp
 
Name: Adrian Kemp
 
Title: Company Secretary