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 February 2017
Commission File
Number: 001-11960
AstraZeneca
PLC
1
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Biomedical Campus
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United
Kingdom
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This announcement contains inside information
24 February 2017 12:30 GMT
ZS-9 (SODIUM ZIRCONIUM CYCLOSILICATE) RECEIVES POSITIVE CHMP
OPINION FOR THE TREATMENT OF HYPERKALAEMIA
AstraZeneca
today announced that the Committee for Medicinal Products for Human
Use (CHMP) of the European Medicines Agency (EMA) has issued a
positive opinion recommending the approval of ZS-9 (sodium
zirconium cyclosilicate) for the treatment of hyperkalaemia, a
serious condition characterised by high potassium levels in the
blood serum caused by cardiovascular, renal and metabolic
diseases.
The
recommendation is based on data from three double-blind
placebo-controlled trials and one ongoing 12-month open-label trial
in adults with hyperkalaemia, representing over 1,600 patients
treated to date.
Results
from a pivotal Phase III study showed that in patients with
hyperkalaemia, sodium zirconium cyclosilicate (oral suspension)
significantly reduced blood serum potassium to normal levels
(normokalaemia) within 48 hours, which was maintained during 12
days of maintenance therapy. Normal levels of potassium in the
blood serum were also achieved within 48 hours in an additional
study, with a higher proportion of patients maintaining
normokalaemia for up to 28 days on treatment versus
placebo.
In
these trials, sodium zirconium cyclosilicate was shown to
significantly lower serum potassium levels quickly and effectively
in patients with acute and chronic hyperkalaemia.1,2
The
condition occurs in 23 to 47% of patients with chronic kidney
disease and/or chronic heart failure, both key strategic areas of
focus for AstraZeneca, and may lead to cardiac arrest and death;
with mortality being up to 30% in patients with severe
hyperkalaemia if not treated rapidly1. As current therapy
options are limited, sodium zirconium cyclosilicate has the
potential to address a long-standing unmet need for the fast, safe
and effective long-term treatment of hyperkalaemia.2,3
The
CHMP's opinion will now be advanced to the European Commission (EC)
for adoption of a decision on EU-wide marketing authorisation of
the medicine. The final decision will be applicable to all 28
European Union member countries plus Iceland, Norway and
Liechtenstein.
Sodium
zirconium cyclosilicate is being developed by ZS Pharma, a
subsidiary of AstraZeneca. It is currently also under regulatory
review in Australia and by the FDA in the US, with decisions
expected in the first half of 2017.
About ZS-9 (sodium zirconium cyclosilicate)
ZS-9
(sodium zirconium cyclosilicate) is an insoluble, non-absorbed
zirconium silicate compound and acts as a highly selective
potassium-removing agent.4 It is odourless and
tasteless. It is non-systemically absorbed, preferentially captures
potassium, and is administered orally in 5 to 10g doses mixed with
three tablespoons of water and is excreted in faeces. Clinical
trials indicate that it is stable at room temperature and has a
rapid onset of action. It 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 to date.
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
rapidly).1
Treatment
with common heart medicines can also be responsible for increases
in hyperkalaemia. Current therapeutic options are limited, leaving
a high unmet medical need, in particular for treatments with rapid
onset of action, chronic use, and no significant drug to drug
interaction risk.
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 ZS Pharma
ZS
Pharma, founded in 2008, was a publicly traded biopharmaceutical
company until it entered into an agreement with AstraZeneca in
November 2015 to be fully acquired. The transaction completed in
December 2015. ZS Pharma has been focused on using its proprietary
ion-trap technology to develop new treatments for kidney and liver
diseases that are focused on addressing unmet needs in the medical
community.
For
more information, please visit: www.zspharma.com.
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 &
Me
tabolic 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.
2.
Packham D, Rasmussen HS, Lavin P, et al. "Sodium Zirconium
Cyclosilicate in Hyperkalemia." New Engl J Med. 2015;372:222-31. doi:
10.1056/NEJMoa1411487.
3. Ash
S, Bhupinder S, Lavin P, et al. "A phase 2 study on the treatment
of hyperkalemia in patients with
chronic kidney disease suggests that the selective potassium trap,
ZS-9, is safe and efficient." Kidney Int. 2015; 88, 404-411.
doi:10.1038/ki.2014.382.
4.
AstraZeneca. "AstraZeneca strengthens Cardiovascular and Metabolic
disease portfolio with acquisition of ZS Pharma." 6 November 2015.
Accessed 5 January 2017. https://www.astrazeneca.com/media-centre/press-releases/2015/AstraZeneca-strengthens-Cardiovascular-and-Metabolic-disease-portfolio-with-acquisition-of-ZS-Pharma-06112015.html
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:
24 February 2017
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
|
|
Title:
Company Secretary
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