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 December
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
Roxadustat approved in China for the treatment of anaemia in
chronic kidney disease patients on dialysis
18 December 2018 09:00 GMT
Roxadustat approved in China for the treatment of
anaemia in chronic kidney disease patients on dialysis
China is the first country to approve roxadustat
AstraZeneca today announced that its partner FibroGen (China)
Medical Technology Development Co., Ltd. (FibroGen China) has now
received formal marketing authorisation from the National Medical
Products Administration (NMPA) for roxadustat, a first-in-class
hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) and
new oral treatment for patients with anaemia caused by chronic
kidney disease (CKD) that are on dialysis. The medicine can be
prescribed to patients who use haemodialysis or peritoneal
dialysis.
Anaemia caused by CKD is associated with cardiovascular disease,
hospitalisation, cognitive impairment and reduced quality of life,
and has been shown consistently to increase the mortality risk in
patients with CKD.1 Anaemia
becomes increasingly common among individuals with CKD as their
disease progresses, affecting nearly all patients at the dialysis
stage.1
Sean Bohen, Executive Vice President, Global Medicines Development
and Chief Medical Officer, said: "Roxadustat is a long-awaited,
first-in-class medicine for patients with anaemia in chronic kidney
disease that are on dialysis. This first approval of roxadustat in
China is a significant step towards achieving our ambition to
transform care in a condition where prevalence in China is
increasing."
Roxadustat is the first approved oral HIF-PHI medicine for patients
with anaemia from CKD. This approval is supported by an open-label,
active-control 26-week Phase III trial in dialysis dependent-CKD
(DD CKD) patients with anaemia who were previously treated with
various forms of a generic erythropoiesis-stimulating agent (ESA).
In the trial, these DD-CKD patients were then randomised to receive
either roxadustat or epoetin alfa, an ESA. Rates of adverse
events related to roxadustat observed in the trial were
generally low (<5%), and mostly of Grade 1-2 severity. The
adverse events observed were consistent with underlying diseases in
patients with CKD.
Anaemia commonly develops in association with CKD and is estimated
to affect 120 million patients in China, with an estimated 0.5
million patients on dialysis who may be suffering from anaemia, a
number that is increasing significantly.2,3
AstraZeneca and FibroGen China are collaborating on the development
and commercialisation of roxadustat in China. FibroGen China,
based in Beijing, is a wholly-owned subsidiary of FibroGen Inc.
that sponsored the development and registration of
roxadustat. FibroGen China conducted the China Phase III
clinical trials and submitted the New Drug Application for
registration of roxadustat to the Chinese regulatory authorities.
Following this approval, AstraZeneca will manage commercialisation
activities in China, and FibroGen China will manage commercial
manufacturing and medical affairs as well as continued clinical
development and regulatory affairs. AstraZeneca and FibroGen expect
to launch roxadustat in China during the second half of
2019.
About roxadustat
Roxadustat is a first-in-class, orally-administered small molecule
currently approved in China for the treatment of patients with
anaemia from CKD on dialysis. Roxadustat is a HIF-PHI that promotes
erythropoiesis by increasing endogenous production of
erythropoietin and improving iron regulation, and overcoming the
negative impact of inflammation on haemoglobin synthesis and red
blood cell production by downregulating hepcidin. Administration of
roxadustat has been shown to induce coordinated erythropoiesis,
increasing red blood cell count while maintaining plasma
erythropoietin levels within or near normal physiologic range, in
multiple subpopulations of CKD patients, including in the presence
of inflammation and without a need for supplemental intravenous
iron.
FibroGen, Inc., the originator, and AstraZeneca are collaborating
on the development and commercialisation of roxadustat for the
treatment of anaemia in patients with CKD in the US, China, and
other global markets. FibroGen and Astellas Pharma Inc. are
collaborating on the development and commercialisation of
roxadustat for the treatment of anaemia in patients with CKD in
territories including Japan, Europe, the Commonwealth of
Independent States, the Middle East, and South Africa.
About anaemia in CKD in China
Anaemia commonly develops in association with CKD and is linked to
significant morbidity and mortality in both the dialysis and
non-dialysis populations. CKD affects an estimated 120 million
patients in China.2 Although CKD may occur at any age, it is more
common in aging populations, and its prevalence is increasing. CKD
can be both a cause and a consequence of cardiovascular disease and
is a critical healthcare issue. There is no treatment available
that is curative or has the ability to stop kidney
deterioration.
About FibroGen
FibroGen, Inc., headquartered in San Francisco, California, with
subsidiary offices in Beijing and Shanghai, People's Republic of
China, is a leading biopharmaceutical company discovering and
developing a pipeline of first-in-class therapeutics. The
company applies its pioneering expertise in hypoxia-inducible
factor (HIF), connective tissue growth factor (CTGF) biology, and
clinical development to advance innovative medicines for the
treatment of anemia, fibrotic disease, and cancer. Roxadustat, the
company's most advanced product candidate, is an oral small
molecule inhibitor of HIF prolyl hydroxylase activity, completing
worldwide Phase 3 clinical development for the treatment of anemia
in chronic kidney disease (CKD), with a New Drug Application (NDA)
now approved by the National Medical Products Administration (NMPA)
in China. Our partner Astellas submitted a NDA for the treatment of
anemia in CKD patients on dialysis in Japan and currently under
review by the Pharmaceuticals and Medical Devices Agency (PMDA).
Roxadustat is in Phase 3 clinical development in the U.S. and
Europe and in Phase 2/3 development in China for anemia associated
with myelodysplastic syndromes (MDS). Pamrevlumab, an
anti-CTGF human monoclonal antibody, is advancing towards Phase 3
clinical development for the treatment of idiopathic pulmonary
fibrosis (IPF) and pancreatic cancer, and is currently in a Phase 2
trial for Duchenne muscular dystrophy (DMD). FibroGen is also
developing a biosynthetic cornea in China. For more information,
please visit www.fibrogen.com.
About AstraZeneca in Cardiovascular, Renal & Metabolism
(CVRM)
Cardiovascular, renal and metabolism together form one of
AstraZeneca's main therapy areas and key growth drivers. 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. Our 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.
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. AstraZeneca operates in over 100
countries and its innovative medicines are used by millions of
patients worldwide. For more information, please
visit astrazeneca.com and
follow us on Twitter @AstraZeneca.
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Adrian Kemp
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AstraZeneca PLC
References
1. Babitt JL, Lin HY. Mechanisms of
Anemia in CKD. J Am Soc
Nephrol (2012);
23:1631-1634.
2. Zhang L, Wang F, Wang L, et
al. Prevalence of chronic kidney disease in China: a
cross-sectional survey. Lancet2012; 379: 815-22.
3.
China National Renal Data System (CNRDS), 2016.
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:
18 December
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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