Blueprint
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 March
2018
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Lokelma
approved in the EU
22
March 2018 16:45 GMT
Lokelma approved in the EU
for the treatment of adults with hyperkalaemia
Patients will benefit from
Lokelma's rapid reduction
and sustained control of potassium levels in the
blood4,5
AstraZeneca
today announced that the European Commission has granted marketing
authorisation for Lokelma
(formerly ZS-9, sodium zirconium cyclosilicate) for the treatment
of adults with hyperkalaemia. Hyperkalaemia is a serious condition
characterised by elevated potassium levels in the blood associated
with cardiovascular, renal and metabolic diseases.1,2,3,4
Lokelma is a highly-selective, oral potassium-removing
agent. The approval is supported by data from three double-blind,
placebo-controlled trials and one open-label trial, where patients
with hyperkalaemia were treated for up to 12 months. In these
trials, for patients receiving Lokelma the median time to achieving
normal potassium levels in the blood was 2.2 hours, with 98%
achieving normal levels within 48 hours from baseline. Lokelma also demonstrated sustained
potassium control for up to one year.4,5
The
risk of hyperkalaemia increases significantly for patients with
chronic kidney disease (CKD) and for those who take common
life-saving medications for heart failure (HF), such as
renin-angiotensin-aldosterone system (RAAS) inhibitors, which can
increase potassium in the blood. To help prevent the recurrence of
hyperkalaemia, RAAS-inhibitor therapy is often modified or
discontinued; this can, however, compromise cardio-renal outcomes
and increase the risk of death.
Elisabeth
Björk, Vice President, Head of Cardiovascular, Renal and
Metabolism, Global Medicines Development, AstraZeneca, said: "The
consequences of hyperkalaemia can be serious, even
life-threatening, and can occur in patients either with chronic
kidney disease or as a result of taking some medications for heart
failure. Today's approval of Lokelma addresses a significant unmet
need by bringing a rapid and sustained therapeutic option for
patients with hyperkalaemia."
Lokelma is currently under
separate regulatory review in the US, with a decision expected in
the first half of 2018.
About Hyperkalaemia
The risk of hyperkalaemia increases significantly for patients with
CKD and for those who take common medications for HF, such as RAAS
inhibitors, which can increase potassium in the blood.
Hyperkalaemia occurs in 23% to 47% of patients with CKD and/or HF,
with an estimated 200 million and 38 million people, respectively,
living with each condition worldwide. Hyperkalaemia may lead to
cardiac arrest and death, with mortality being up to 30% in
patients with severe hyperkalaemia, if not treated
rapidly.
About Lokelma
Lokelma is an insoluble,
non-absorbed sodium zirconium silicate, formulated as a powder for
oral suspension, that acts as a highly-selective potassium-removing
agent. It is administered orally, is odourless, tasteless and
stable at room temperature. It has been studied in three
double-blind, placebo-controlled trials and in one 12-month open
label clinical trial in patients with hyperkalaemia. The
recommended starting dose of Lokelma is 10g, administered three times daily. Once
normokalaemia (normal potassium levels in the blood) has been
achieved, a maintenance dose of 5g once daily is recommended with
possible titration up to 10g daily or down to 5g once every other
day to maintain a normal potassium level.
About AstraZeneca in Cardiovascular, Renal &
Metabolism
Cardiovascular and metabolic diseases are a main therapy area and a
key growth platform for AstraZeneca, which is now called
Cardiovascular, Renal & Metabolism (CVRM), following the
addition of Lokelma to our portfolio of medicines.
By following the science to understand more clearly the underlying
links between the heart, kidney and pancreas, AstraZeneca is
investing in a portfolio of medicines to protect organs and improve
outcomes by slowing disease progression, reducing risks and
tackling co-morbidities. Our ambition is to modify or halt the
natural course of these diseases and even regenerate organs and
restore function, by continuing to deliver transformative science
that improves treatment practices and CVRM health for millions of
patients worldwide.
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 therapy areas - Oncology, Cardiovascular, Renal &
Metabolism 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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Adrian Kemp
Company Secretary
AstraZeneca PLC
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 National Kidney Foundation. 'Clinical Update on
Hyperkalemia." 2014. Accessed 5 January 2017.
https://www.kidney.org/sites/default/files/02-10-6785_HBE_Hyperkalemia_Bulletin.pdf.
5 Fishbane S, Pergola PE, Packham DK, et al. 'Long-term
Efficacy and Safety of Sodium Zirconium Cyclosilicate for
Hyperkalemia: A 12-Month, Open-Label, Phase 3 Study'. Poster
presentation at: American Society of Nephrology Kidney Week;
November 2017; New Orleans, LA. TH-PO1112.
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.
Date:
22 March
2018
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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