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 August
2019
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.
Roxadustat
approved in China for the treatment of anaemia
22 August 2019 07:00 BST
Roxadustat approved in China for the treatment of anaemia
in
non-dialysis-dependent patients with chronic kidney
disease
China is the first country to approve roxadustat for
all
chronic kidney disease patients with anaemia
AstraZeneca today announced that its partner FibroGen (China)
Medical Technology Development Co., Ltd. (FibroGen China) has
received marketing authorisation for roxadustat in China for
the treatment of anaemia caused by chronic kidney disease (CKD) in
non-dialysis-dependent (NDD) patients.
This approval, granted by the National Medical Products
Administration, is primarily supported by a Phase III trial in
NDD-CKD patients with anaemia, in which roxadustat demonstrated a
statistically-significant improvement in haemoglobin levels from
baseline averaged over weeks seven to nine of treatment, with a
mean change of 1.9 g/dL compared to -0.4 g/dL with placebo. This
data was published in The
New England Journal of Medicine in July 2019.
This marketing authorisation follows the approval of roxadustat in
China in December 2018 for anaemia in CKD patients who are on
dialysis. AstraZeneca and FibroGen China expect to launch
roxadustat in China during the second half of 2019.
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "With this approval for roxadustat in China, we are
now able to provide this first-in-class medicine to all patients
living with chronic kidney disease who experience anaemia,
regardless of whether they require dialysis. This is a significant
milestone and we look forward to bringing the medicine to patients
later this year."
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 risk of death in
patients with CKD.1 Anaemia
becomes increasingly common in patients with CKD as their disease
progresses.1
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 and not on dialysis. Roxadustat is a
hypoxia-inducible factor prolyl hydroxylase inhibitor 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.
About the AstraZeneca and FibroGen China collaboration
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.
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 AstraZeneca in CV, renal and metabolism (CVRM)
CVRM together form one of AstraZeneca's main therapy areas and 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. 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, CVRM 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.
Media
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Adrian Kemp
Company Secretary
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. Lancet 2012; 379: 815-22.
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 August
2019
|
By: /s/
Adrian Kemp
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Name:
Adrian Kemp
|
|
Title:
Company Secretary
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