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 May
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.
US FDA approves Lokelma for adult
hyperkalaemia
21 May
2018 07:00 BST
Lokelma approved in the US
for the treatment of adults with hyperkalaemia
Lokelma provides
rapid and sustained potassium control for
patients
in a condition with high unmet need
The US
Food and Drug Administration (FDA) has approved Lokelma (sodium zirconium
cyclosilicate), formerly ZS-9, for the treatment of adults with
hyperkalaemia,1 a serious condition
characterised by elevated potassium levels in the blood associated
with cardiovascular, renal and metabolic diseases.2
The
risk of hyperkalaemia increases significantly for patients with
chronic kidney disease (CKD) and for those who take common
medications for heart failure (HF), such as
renin-angiotensin-aldosterone system (RAAS) inhibitors, which can
increase potassium in the blood.2,3 To help prevent
the recurrence of hyperkalaemia, RAAS-inhibitor therapy is often
modified or discontinued, which can compromise cardio-renal
outcomes and increase the risk of death.3,4
Sean
Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer at AstraZeneca, said: "We are pleased by
today's FDA approval of Lokelma as it enables us to help
address a long-standing clinical need with a new medicine that
offers rapid and sustained treatment for adults with hyperkalaemia.
The consequences of hyperkalaemia can be very serious and it's
reassuring for treating physicians that Lokelma has demonstrated lowering of potassium levels in
patients with chronic kidney disease, heart failure, diabetes and
those taking RAAS inhibitors."
Lokelma is a highly-selective, oral potassium-removing
agent.1
The FDA approval is supported by data from three double-blind,
placebo-controlled trials and two open-label trials, which
showed that for patients
receiving Lokelma the onset of action was at 1.0 hour and the median
time to achieving normal potassium levels in the blood was 2.2
hours, with 92% of patients achieving normal potassium levels
within 48 hours from baseline.1,8
The treatment effect was
maintained for up to 12 months.1,5,6,7,8
Steven
Fishbane, MD, Professor, Donald and Barbara Zucker School of
Medicine at Hofstra Northwell, New York, said: "This FDA approval
represents an exciting milestone, as it stands to deliver a rapid,
effective and generally well-tolerated treatment option to patients
suffering from hyperkalaemia in the US."
The
European Commission granted marketing authorisation for
Lokelma in the European
Union on 22 March 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 two 12-month open label clinical trials in adult patients
with hyperkalaemia.
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 AstraZeneca. Lokelma Prescribing Information. May
2018.
2 National Kidney Foundation.
"Clinical Update on Hyperkalemia." 2014. Accessed 8 May
2018. https://www.kidney.org/sites/default/files/02-10-6785_HBE_Hyperkalemia_Bulletin.pdf.
3 Kuijvenhoven MA, Haak EA, Gombert-Handoko KB, Crul M.
Evaluation of the concurrent use of potassium-influencing drugs as
risk factors for the development of hyperkalemia. Int J Clin Pharm. 2013
Dec;35(6):1099-104.
4 Epstein M, Reaven NL, Funk SE, McGaughey KJ, Oestreicher
N, Knispel J. Evaluation of the treatment gap between clinical
guidelines and the utilization of renin-angiotensin-aldosterone
system inhibitors. Am J Manag
Care. 2015 Sep;21(11 Suppl):S212-S220.
5 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.
6 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.
7 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.
8 Fishbane S, Pergola PE, Packham DK, et al. Long-term
efficacy and safety of sodium zirconium cyclosilicate for
hyperkalemia: 12-month, open-label, phase 3 study. Poster
presentation at: American Society of Nephrology Kidney Week 2017;
November 2017; New Orleans, LA. Abstract #2759765.
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:
21 May 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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