<SEC-DOCUMENT>0001654954-20-003241.txt : 20200326
<SEC-HEADER>0001654954-20-003241.hdr.sgml : 20200326
<ACCEPTANCE-DATETIME>20200326061304
ACCESSION NUMBER:		0001654954-20-003241
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20200326
FILED AS OF DATE:		20200326
DATE AS OF CHANGE:		20200326

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			ASTRAZENECA PLC
		CENTRAL INDEX KEY:			0000901832
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-11960
		FILM NUMBER:		20743906

	BUSINESS ADDRESS:	
		STREET 1:		1 FRANCIS CRICK AVENUE
		STREET 2:		CAMBRIDGE BIOMEDICAL CAMPUS
		CITY:			CAMBRIDGE
		STATE:			X0
		ZIP:			CB2 0AA
		BUSINESS PHONE:		011 44 20 7304 5000

	MAIL ADDRESS:	
		STREET 1:		1 FRANCIS CRICK AVENUE
		STREET 2:		CAMBRIDGE BIOMEDICAL CAMPUS
		CITY:			CAMBRIDGE
		STATE:			X0
		ZIP:			CB2 0AA

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	ZENECA GROUP PLC
		DATE OF NAME CHANGE:	19930422
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>a6835h.htm
<DESCRIPTION>LOKELMA APPROVED IN JAPAN FOR THE TREATMENT OF HYPERKALAEMIA
<TEXT>
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<font style="font-size: 13px; font-family: Times New Roman">1.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-weight: bold; font-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">
Lokelma</font><font style="color: #000000">&#xA0;approved in Japan
for the treatment of hyperkalaemia</font></font></div>
</div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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&#xA0;</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
26 March 2020 07:00 GMT</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
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<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
<font style="font-style: italic; color: #000000">Lokelma</font><font style="color: #000000">&#xA0;approved in Japan for the treatment of
hyperkalaemia</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
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<font style="color: #000000; font-weight: bold; font-style: italic; font-family: Times New Roman; font-size: 13px">
Patients in Japan will benefit from Lokelma's rapid and sustained
potassium control</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
AstraZeneca's&#xA0;</font><font style="font-style: italic; color: #000000">Lokelma</font><font style="color: #000000">&#xA0;(sodium zirconium cyclosilicate) has been
approved in Japan for the treatment of patients with hyperkalaemia
(elevated levels of potassium in the blood).</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
The approval&#xA0;by&#xA0;Japan's Ministry of Health, Labour and
Welfare&#xA0;was based on positive results from stand-alone studies
in Japan and global clinical trial programmes. It was also
supported by DIALIZE, a global trial for&#xA0;end-stage renal
disease patients on&#xA0;haemodialysis, which demonstrated the
positive efficacy and safety of&#xA0;</font><font style="font-style: italic; color: #000000">Lokelma</font><font style="color: #000000">&#xA0;in&#xA0;</font><font style="color: #000000; background-color: #FFFFFF">the management
of</font><font style="color: #000000; font-size: 13px; background-color: #FFFFFF">&#xA0;</font><font style="color: #000000">hyperkalaemia.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">
Lokelma</font><font style="color: #000000">&#xA0;is the first
innovative non-resin potassium binder to be approved in Japan.
Traditional resin-based binders are often associated with poor
tolerability.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&amp;D, said: "More than 300,000 patients in Japan suffer from
hyperkalaemia, typically as result of chronic kidney disease or as
a side effect from medications for heart failure. This approval
ensures that this broad patient population,&#xA0;including those
suffering from hyperkalaemia and patients with hyperkalaemia on
stable haemodialysis, can benefit from&#xA0;</font><font style="font-style: italic; color: #000000">Lokelma</font><font style="color: #000000">'s rapid, sustained potassium control and
tolerability."</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
The global clinical trial programme showed that for patients
receiving&#xA0;</font><font style="font-style: italic; color: #000000">Lokelma</font><font style="color: #000000">, for up to 12-months in duration, 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.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font><font style="color: #000000">&#xA0;</font><font style="font-style: italic; color: #000000">Lokelma</font><font style="color: #000000">&#xA0;demonstrated
a rapid reduction of potassium in the blood as early as one hour
with one dose and a sustained treatment effect for up to one
year.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2,3</font><font style="color: #000000">&#xA0;In
the DIALIZE trial,&#xA0;</font><font style="font-style: italic; color: #000000">Lokelma</font><font style="color: #000000">&#xA0;demonstrated significantly improved control
of pre-dialysis hyperkalaemia compared with
placebo.</font><font style="font-size: 70%; vertical-align: top; color: #000000">4</font><font style="color: #000000">&#xA0;</font><font style="font-style: italic; color: #000000">Lokelma</font><font style="color: #000000">&#xA0;was
well tolerated, with few serious adverse events.</font><font style="font-size: 70%; vertical-align: top; color: #000000">3,4</font><font style="color: #000000">&#xA0;Results
in Japanese patients were broadly consistent with those seen in the
global programme.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">
Lokelma</font><font style="color: #000000">&#xA0;is approved for
the treatment of hyperkalaemia in the US, EU, Canada, Hong Kong,
China, Russia and Japan.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
Hyperkalaemia</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
High levels of potassium in the blood (generally classified as
&gt;5mmol/l)</font><font style="font-size: 70%; vertical-align: top; color: #000000">5</font><font style="color: #000000">&#xA0;characterise
hyperkalaemia. 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 inhibitors, which can increase
potassium in the blood. Hyperkalaemia occurs in 23% to 47% of
patients with CKD and/or HF with an estimated 700 million and 64
million people, respectively, living with each condition
worldwide.</font><font style="font-size: 70%; vertical-align: top; color: #000000">6,7</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
Lokelma</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">
Lokelma</font><font style="color: #000000">&#xA0;(sodium zirconium
cyclosilicate)&#xA0;is an insoluble, non-absorbed sodium zirconium
silicate, formulated as a powder for oral suspension, that acts as
a highly selective potassium-removing medicine. It is administered
orally, is odourless, tasteless and stable at room temperature.
The&#xA0;</font><font style="font-style: italic; color: #000000">Lokelma</font><font style="color: #000000">&#xA0;global clinical trials programme consists of
multiple trials of up to 12-months duration. The Japan clinical
data package included 11 trials; four pivotal trials that Japanese
patients participated in and seven supportive overseas trials. The
efficacy and safety of&#xA0;</font><font style="font-style: italic; color: #000000">Lokelma</font><font style="color: #000000">&#xA0;in Japanese patients were evaluated
primarily in Japan stand-alone trials and international trials
including Japanese patients.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
AstraZeneca in CVRM</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
Cardiovascular, Renal and Metabolism (CVRM) together forms one of
AstraZeneca's three therapy areas and is a key growth driver for
the Company. By following the science to understand more clearly
the underlying links between the heart, kidneys 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. The Company's ambition
is to modify or halt the natural course of CVRM diseases and
potentially regenerate organs and restore function, by continuing
to deliver transformative science that improves treatment practices
and cardiovascular health for millions of patients
worldwide.</font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
AstraZeneca</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
AstraZeneca&#xA0;(LSE/STO/NYSE: AZN)&#xA0;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 and Metabolism, and Respiratory.
Based in Cambridge, UK, AstraZeneca operates in over 100 countries
and its innovative medicines are used by millions of patients
worldwide. Please visit&#xA0;</font><font style="text-decoration: underline; color: #0000FF">astrazeneca.com</font><font style="color: #000000">&#xA0;and
follow the Company on Twitter&#xA0;</font><font style="text-decoration: underline; color: #0000FF">@</font><font style="text-decoration: underline; color: #0000FF">AstraZeneca</font><font style="text-decoration: underline; color: #0000FF">.</font></font></div>
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References</font></div>
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1. Kosiborod M et al.&#xA0;Effect of Sodium Zirconium Cyclosilicate
on Potassium Lowering for 28 Days Among Outpatients With
Hyperkalemia: The HARMONIZE Randomized Clinical
Trial.&#xA0;</font><font style="font-style: italic; color: #000000">JAMA</font><font style="color: #000000">. 2014;312(21):2223-2233.</font></font></div>
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2. Ash S 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.&#xA0;</font><font style="font-style: italic; color: #000000">Kidney Int</font><font style="color: #000000">. 2015; 88, 404-411.</font></font></div>
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3. Roger SD et al. Efficacy and Safety of Sodium Zirconium
Cyclosilicate for Treatment of Hyperkalemia: An 11-Month Open-Label
Extension of HARMONIZE.</font><font style="color: #000000">&#xA0;</font><font style="font-style: italic; color: #000000; font-size: 13px">Am J
Nephrol</font><font style="color: #000000; font-size: 13px">.
2019;50(6):473-480.</font></font></div>
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4. Fishbane S et al. Long-term Efficacy and Safety of Sodium
Zirconium Cyclosilicate for Hyperkalemia: A 12-Month, Open-Label,
Phase 3 Study.&#xA0;</font><font style="font-style: italic; color: #000000">Clin J Am Soc
Nephrol.</font><font style="color: #000000">&#xA0;2019;30.9,
1723-1733.</font></font></div>
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5. National Kidney Foundation. Clinical Update on Hyperkalemia.
2014. Accessed 24 February 2020.
https://www.kidney.org/sites/default/files/02-10-6785_HBE_Hyperkalemia_Bulletin.pdf</font></div>
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6. Vos T, et al. Global, Regional, and National Incidence,
Prevalence, and Years Lived with Disability for 328 Diseases and
Injuries for 195 Countries, 1990-2016: A Systematic Analysis for
the Global Burden of Disease Study 2016.&#xA0;</font><font style="font-style: italic; color: #000000">The Lancet</font><font style="color: #000000">. 2017; 390:1211-59.</font></font></div>
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7.</font><font style="color: #000000">&#xA0;</font><font style="color: #000000; font-size: 13px">James SL et al. Global, regional,
and national incidence, prevalence, and years lived with disability
for 354 diseases and injuries for 195 countries and territories,
1990-2017: A systematic analysis for the Global Burden of Disease
Study 2017.&#xA0;</font><font style="font-style: italic; color: #000000; font-size: 13px">The
Lancet</font><font style="color: #000000; font-size: 13px">&#xA0;2018;
392(10159):1789-858.</font></font></div>
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Adrian Kemp</font></div>
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Company Secretary</font></div>
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AstraZeneca PLC</font></div>
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SIGNATURES</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">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.</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">AstraZeneca
PLC</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Date:
<font style="font-weight: bold; font-size: 13px">26 March
2020</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px">By: /s/
Adrian Kemp</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Name:
Adrian Kemp</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Title:
Company Secretary</font></div>
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