<SEC-DOCUMENT>0001654954-22-011790.txt : 20220825
<SEC-HEADER>0001654954-22-011790.hdr.sgml : 20220825
<ACCEPTANCE-DATETIME>20220825064645
ACCESSION NUMBER:		0001654954-22-011790
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20220825
FILED AS OF DATE:		20220825
DATE AS OF CHANGE:		20220825

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			ASTRAZENECA PLC
		CENTRAL INDEX KEY:			0000901832
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			X0
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-11960
		FILM NUMBER:		221192932

	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>a1489x.htm
<DESCRIPTION>ULTOMIRIS APPROVED IN JAPAN FOR GMG
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<font style="font-family: Times New Roman; font-size: 13px">INDEX
TO EXHIBITS</font></div>
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<font style="font-size: 13px; font-weight: bold; font-style: italic; font-family: Times New Roman">1.</font>
<font style="font-weight: bold; font-style: italic; font-family: Times New Roman; font-size: 13px">
Ultomiris approved in Japan for gMG</font>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
25 August 2022 07:10 BST</font></div>
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&#xA0;</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="font-weight: bold; font-style: italic; color: #000000">
Ultomiris</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="font-weight: bold; color: #000000">approved
in Japan for the treatment of adults with generalised myasthenia
gravis</font></font></div>
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<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
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<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
First and only long-acting C5 complement inhibitor offers early
onset and sustained efficacy, and has the potential to reduce
treatment burden with dosing every 8 weeks&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #FF0000; 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">
Ultomiris</font><font style="color: #000000">&#xA0;(ravulizumab)
has been approved in Japan for the treatment of adult patients with
generalised myasthenia gravis (gMG) who are anti-acetylcholine
receptor (AChR) antibody-positive and whose symptoms are difficult
to control with high-dose intravenous immunoglobulin therapy (IVIg)
or plasmaphaeresis.&#xA0;Japan's Pharmaceuticals and Medical
Devices Agency also indicated that&#xA0;</font><font style="font-style: italic; color: #000000">Ultomiris</font><font style="color: #000000">&#xA0;can be considered for patients who cannot
receive high-dose IVIg or plasmaphaeresis due to complications,
adverse reactions or other limiting factors.</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 of&#xA0;the first and only long-acting C5 complement
inhibitor&#xA0;by the Japanese Ministry of Health, Labour and
Welfare (MHLW) was based on positive results from the CHAMPION-MG
Phase III trial, which showed&#xA0;</font><font style="font-style: italic; color: #000000">Ultomiris</font><font style="color: #000000">&#xA0;was superior to placebo in the primary
endpoint of change from baseline in the Myasthenia
Gravis-Activities of Daily Living Profile (MG-ADL) total score at
Week 26, a patient-reported scale that assesses patients' abilities
to perform daily activities.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font><font style="color: #000000">&#xA0;Additionally,
in prolonged follow-up results from the open-label extension,
clinical benefit of&#xA0;</font><font style="font-style: italic; color: #000000">Ultomiris</font><font style="color: #000000">&#xA0;was observed through 60
weeks.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</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">
gMG is a rare, debilitating, chronic, autoimmune neuromuscular
disease that leads to a loss of muscle function and severe
weakness.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2</font><font style="color: #000000">&#xA0;The
diagnosed prevalence of gMG in Japan is estimated at approximately
22,000.</font><font style="font-size: 70%; vertical-align: top; color: #000000">3</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">
Hiroyuki Murai, MD, PhD, Professor and Chairman, Department of
Neurology,&#xA0;</font><font style="color: #000000; background-color: #FFFFFF">School of
Medicine,</font><font style="color: #000000">&#xA0;International
University of Health and Welfare, Narita, Japan, said: "C5
inhibition is a proven approach to manage gMG. The approval
of&#xA0;</font><font style="font-style: italic; color: #000000">Ultomiris</font><font style="color: #000000">&#xA0;is an important advance for the gMG
community in Japan, offering patients and physicians a new
long-acting C5 inhibitor that has demonstrated sustained
improvement in activities of daily living through 60 weeks, with
fewer infusions per year over current
treatment."</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #FF0000; 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">
Marc Dunoyer, Chief Executive Officer, Alexion, said: "We are
pleased that&#xA0;</font><font style="font-style: italic; color: #000000">Ultomiris</font><font style="color: #000000">&#xA0;is now approved in Japan for adults with
gMG, a disease that&#xA0;may impact their ability to work, meet
family obligations and live their lives fully. The approval speaks
to the strength and consistency of&#xA0;</font><font style="font-style: italic; color: #000000">Ultomiris</font><font style="color: #000000">&#xA0;clinical data as demonstrated in the global
CHAMPION-MG Phase III trial. We look forward to bringing this
treatment option to people living with gMG in Japan as part of our
broader strategy to expand global access to our medicines."&#xA0;
&#xA0;</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #FF0000; 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">
In CHAMPION-MG, the safety profile of&#xA0;</font><font style="font-style: italic; color: #000000">Ultomiris</font><font style="color: #000000">&#xA0;was comparable to placebo and consistent
with that observed in Phase III trials of&#xA0;</font><font style="font-style: italic; color: #000000">Ultomiris</font><font style="color: #000000">&#xA0;in paroxysmal nocturnal haemoglobinuria
(PNH) and atypical haemolytic uraemic syndrome (aHUS). The most
common adverse reactions in patients
receiving&#xA0;</font><font style="font-style: italic; color: #000000">Ultomiris</font><font style="color: #000000">&#xA0;were nausea, headache and
diarrhoea.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font></font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#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">
Results from the CHAMPION-MG trial were
published&#xA0;</font><font style="text-decoration: underline; color: #0000FF">online</font><font style="color: #0000FF">&#xA0;</font><font style="color: #000000">in&#xA0;</font><font style="font-style: italic; color: #000000">NEJM
Evidence</font><font style="color: #000000">&#xA0;and presented at
the 2022 American Academy of Neurology Annual Meeting in
April.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #FF0000; 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">
Ultomiris</font><font style="color: #000000">&#xA0;was&#xA0;</font><font style="text-decoration: underline; color: #0000FF">approved in the
US</font><font style="color: #000000">&#xA0;for adults with
anti-AChR antibody-positive gMG in April, and regulatory reviews
are ongoing in additional countries. It was recently recommended
for marketing authorisation in the European Union as an add-on to
standard therapy for the treatment of adult patients with gMG who
are anti-AChR antibody-positive.</font></font></div>
<div style="text-align: left; 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>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="text-decoration: underline; color: #000000; font-weight: bold; font-family: Times New Roman; font-size: 13px">
Notes</font></div>
<div style="text-align: left; 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>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
gMG</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">
gMG is a rare autoimmune disorder&#xA0;characterised&#xA0;by loss
of muscle function and severe muscle weakness.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2</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">
Eighty percent of people with gMG are AChR antibody-positive
meaning they produce specific antibodies (anti-AChR) that bind to
signal receptors at the neuromuscular junction (NMJ), the
connection point between&#xA0;nerve cells and the muscles they
control.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2,4-7</font><font style="color: #000000">&#xA0;This
binding activates the complement system, which is essential to the
body's defence against infection, causing the immune system to
attack the NMJ.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2</font><font style="color: #000000">&#xA0;This
leads to inflammation and a breakdown in communication between the
brain and the muscles.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2</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">
gMG can occur at any age, but it most commonly begins for women
before the age of 40 and for men after the age of
60.</font><font style="font-size: 70%; vertical-align: top; color: #000000">8-10</font><font style="color: #000000">&#xA0;Initial
symptoms may include slurred speech, double vision, droopy eyelids
and lack of balance; these can often lead to more severe symptoms
as the disease progresses such as, impaired swallowing, choking,
extreme fatigue and respiratory failure.</font><font style="font-size: 70%; vertical-align: top; color: #000000">11,12</font></font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
CHAMPION-MG</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
The global Phase III randomised, double-blind, placebo-controlled,
multicentre 26-week trial evaluated the safety and efficacy
of&#xA0;</font><font style="font-style: italic; color: #000000">Ultomiris</font><font style="color: #000000">&#xA0;in adults with gMG. The trial enrolled 175
patients across North America, Europe, Asia-Pacific and Japan.
Participants were required to have a confirmed myasthenia gravis
diagnosis at least six months prior to the screening visit with a
positive serologic test for anti-AChR antibodies, MG-ADL total
score of at least 6 at trial entry and Myasthenia Gravis Foundation
of America Clinical Classification Class II to IV at screening.
Patients could stay on stable standard of care medicines, with a
few exceptions, for the duration of the randomised control
period.</font><font style="font-size: 70%; vertical-align: top; color: #000000">13</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Patients were randomised 1:1 to receive&#xA0;</font><font style="font-style: italic; color: #000000">Ultomiris</font><font style="color: #000000">&#xA0;or placebo for a total of 26 weeks. Patients
received a single weight-based loading dose on Day 1, followed by
regular weight-based maintenance dosing beginning on Day 15, every
eight weeks. The primary endpoint of change from baseline in the
MG-ADL total score at Week 26 was assessed along with multiple
secondary endpoints evaluating improvement in disease-related and
quality-of-life measures.</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Patients who completed the randomised control period were eligible
to continue into an open-label extension period evaluating the
safety and efficacy of&#xA0;</font><font style="font-style: italic; color: #000000">Ultomiris</font><font style="color: #000000">, which is ongoing.</font></font></div>
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Ultomiris</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">
Ultomiris</font><font style="color: #000000">&#xA0;(ravulizumab),
the first and only long-acting C5 complement inhibitor, offers
immediate, complete and sustained complement inhibition. The
medication works by inhibiting the C5 protein in the terminal
complement cascade, a part of the body's immune system. When
activated in an uncontrolled manner, the complement cascade
over-responds, leading the body to attack its own healthy
cells.&#xA0;</font><font style="font-style: italic; color: #000000">Ultomiris</font><font style="color: #000000">&#xA0;is administered intravenously every eight
weeks in adult patients, following a loading
dose.&#xA0;</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">
Ultomiris</font><font style="color: #000000">&#xA0;is approved in
the US and Japan for the treatment of certain adults with
gMG.</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">
Ultomiris</font><font style="color: #000000">&#xA0;is also approved
in the US, EU and Japan for the treatment of certain adults with
PNH and for certain children with&#xA0;PNH in the US and
EU.&#xA0;</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Additionally,&#xA0;</font><font style="font-style: italic; color: #000000">Ultomiris</font><font style="color: #000000">&#xA0;is approved in the US, EU and Japan for
certain adults and children with aHUS to inhibit
complement-mediated thrombotic microangiopathy.</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
As part of a broad development programme,&#xA0;</font><font style="font-style: italic; color: #000000">Ultomiris</font><font style="color: #000000">&#xA0;is being assessed for the treatment of
additional haematology and neurology
indications.</font></font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
Alexion</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
Alexion, AstraZeneca Rare Disease, is the group within AstraZeneca
focused on rare diseases, created following the 2021 acquisition of
Alexion Pharmaceuticals, Inc. As a leader in rare diseases for
nearly 30 years, Alexion is focused on serving patients and
families affected by rare diseases and devastating conditions
through the discovery, development and commercialisation of
life-changing medicines. Alexion focuses its research efforts on
novel molecules and targets in the complement cascade and its
development efforts on haematology, nephrology, neurology,
metabolic disorders, cardiology and ophthalmology. Headquartered in
Boston, Massachusetts, Alexion has offices around the globe and
serves patients in more than 50 countries.</font></div>
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AstraZeneca</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led
biopharmaceutical company that focuses on the discovery,
development, and commercialisation of prescription medicines in
Oncology, Rare Diseases, and BioPharmaceuticals, including
Cardiovascular, Renal &amp; Metabolism, and Respiratory &amp;
Immunology. 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">@AstraZeneca</font><font style="color: #000000">.</font></font></div>
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Contacts</font></div>
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For details on how to contact the Investor Relations Team, please
click&#xA0;</font><font style="text-decoration: underline; color: #0000FF">here</font><font style="color: #000000">.
For Media contacts, click&#xA0;</font><font style="text-decoration: underline; color: #0000FF">here</font><font style="color: #000000">.</font></font></div>
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References</font></div>
<div style="text-align: left; margin-left: 48px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">1.&#xA0;&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="font-style: italic; color: #000000; font-size: 13px">Ultomiris</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">(ravulizumab)
Japanese prescribing information; 2022.</font></font></div>
<div style="text-align: left; margin-left: 48px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">2.&#xA0;&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">Howard,
J. F., (2017). Myasthenia gravis: the role of complement at the
neuromuscular junction. Annals of The New York Academy of Sciences,
1412(1), 113-128.</font></font></div>
<div style="text-align: left; margin-left: 48px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">3.&#xA0;&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">Lai,
CH., Tseng, HK., (2010). Nationwide Population-Based
Epidemiological Study of Myasthenia Gravis in Taiwan.
Neuroepidemiology. 2010 June;35:66-71. 7.</font></font></div>
<div style="text-align: left; margin-left: 48px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">4.&#xA0;&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">Anil,
R., Kumar, A., Alaparthi, S., Sharma, A., Nye, JL., Roy, B.,
O'Connor, KC., Nowak, R., (2020). Exploring outcomes and
characteristics of myasthenia gravis: Rationale, aims and design of
registry - The EXPLORE-MG registry. J Neurol Sci. 2020 Jul
15;414:116830.</font></font></div>
<div style="text-align: left; margin-left: 48px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">5.&#xA0;&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">Oh
SJ., (2009). Muscle-specific receptor tyrosine kinase antibody
positive myasthenia gravis current status. Journal of Clinical
Neurology. 2009b Jun 1;5(2):53-64.</font></font></div>
<div style="text-align: left; margin-left: 48px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">6.&#xA0;&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">Tomschik,
M., Hilger, E., Rath, J., Mayer, EM., Fahrner, M., Cetin, H.,
L&#xF6;scher, W., Zimprich, F., (2020). Subgroup stratification and
outcome in recently diagnosed generalized myasthenia gravis.
Neurology. 2020 Sep 8;95(10):e1426-e1436.</font></font></div>
<div style="text-align: left; margin-left: 48px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">7.&#xA0;&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">Hendricks,
TM., Bhatti, MT., Hodge, D., Chen, J., (2019). Incidence,
Epidemiology, and Transformation of Ocular Myasthenia Gravis: A
Population-Based Study. Am J Ophthalmol. 2019
Sep;205:99-105.</font></font></div>
<div style="text-align: left; margin-left: 48px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">8.&#xA0;&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">Myasthenia
Gravis. National Organization for Rare Disorders (NORD).
Available</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">here</font><font style="color: #000000; font-size: 13px">.
Accessed March 2022.</font></font></div>
<div style="text-align: left; margin-left: 48px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">9.&#xA0;&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">Howard,
J. F., (2015). Clinical Overview of MG.
Available</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">here</font><font style="color: #000000; font-size: 13px">.
Accessed March 2022.</font></font></div>
<div style="text-align: left; margin-left: 48px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">10.&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">Sanders,
D. B., Raja, S. M., Guptill J. T., Hobson-Webb, L. D., Juel, V. C.,
&amp; Massey, J. M., (2020). The Duke myasthenia gravis clinic
registry: I. Description and demographics. Muscle &amp; Nerve,
63(2), 209-216.</font></font></div>
<div style="text-align: left; margin-left: 48px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">11.&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">Myasthenia
Gravis Fact Sheet. (2020, April 27). National Institutes of
Neurological Disorders and Stroke. Available</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">here</font><font style="color: #000000; font-size: 13px">.
Accessed March 2022.</font></font></div>
<div style="text-align: left; margin-left: 48px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">12.&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">Ding,
J., Zhao, S., Ren, K., Dang, D., Li, H., Wu, F., Zhang, M., Li, Z.,
&amp; Guo, J., (2020). Prediction of generalization of ocular
myasthenia gravis under immunosuppressive therapy in Northwest
China. BMC Neurology, 20(238).</font></font></div>
<div style="text-align: left; margin-left: 48px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">13.&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">ClinicalTrials.gov.
Safety and Efficacy Study of Ravulizumab in Adults With Generalized
Myasthenia Gravis. NCT Identifier: NCT03920293.
Available</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">here</font><font style="color: #000000; font-size: 13px">.
Accessed March 2022.</font></font></div>
<div style="text-align: left; 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: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
Adrian Kemp</font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
Company Secretary</font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
AstraZeneca PLC</font></div>
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SIGNATURES</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</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-size: 13px">25 August 2022</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px">By: /s/
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<font style="font-family: Times New Roman; font-size: 13px">Name:
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