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 2020
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.
Update on
US regulatory review of roxadustat in anaemia of chronic kidney
disease
18 December 2020 22:00 GMT
Update on US regulatory review of roxadustat
in anaemia of chronic kidney disease
The US Food and Drug Administration (FDA) has
requested further clarifying analyses of clinical
data, to complete its review of the New Drug Application (NDA)
for roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase
(HIF-PH) inhibitor for patients with anaemia of chronic kidney
disease (CKD).
AstraZeneca and FibroGen, Inc. (FibroGen) are committed to working
with the FDA and have agreed to submit the additional clarifying
analyses as soon as possible to assist with the completion of
labelling discussions.
The NDA remains under regulatory review, with the FDA having set a
new action date of 20 March 2021.
Anaemia
Anaemia can be a serious medical condition in which patients have
insufficient red blood cells (RBCs) and low levels of haemoglobin,
a protein in RBCs that carries oxygen to cells throughout the
body.1 Anaemia
of CKD is associated with increased risk of hospitalisation,
cardiovascular complications and death, also frequently
causing significant fatigue, cognitive dysfunction and decreased
quality of life.2,3 Severe
anaemia is common in patients with CKD, cancer, myelodysplastic
syndrome (MDS), inflammatory diseases and other serious illnesses.
Anaemia is particularly prevalent in patients with
CKD.2 CKD
affects nearly 700 million patients worldwide and is generally
progressive, characterised by gradual loss of kidney function that
may eventually lead to kidney failure.4
Roxadustat
Roxadustat, an oral medicine, is the first in a new class of
medicines called HIF-PH inhibitors that promotes erythropoiesis, or
red blood cell production, through increased endogenous production
of erythropoietin, improved iron absorption and mobilisation, and
downregulation of hepcidin. Roxadustat is also in clinical
development for anaemia associated with MDS and for
chemotherapy-induced anaemia.
Roxadustat is approved in China, Japan (under the
name Evrenzo), and Chile for the treatment of anaemia in CKD
in non-dialysis dependent (NDD) and dialysis-dependent (DD) adult
patients. In Europe, the Marketing Authorisation Application
for Evrenzo for the treatment of anaemia in CKD in NDD
and DD patients was submitted by Astellas Pharma Inc. (Astellas)
and accepted by the European Medicines Agency for review in May
2020.
AstraZeneca and FibroGen are collaborating on the development and
commercialisation of roxadustat for the potential treatment of
anaemia in the US, China and other markets in the Americas,
Australia and New Zealand, as well as Southeast Asia. Astellas and
FibroGen are collaborating on the development and commercialisation
of roxadustat for the potential treatment of anaemia in territories
including Japan, Europe, Turkey, Russia and the Commonwealth of
Independent States, the Middle East and South Africa.
Phase III programme
AstraZeneca, FibroGen and Astellas conducted the pivotal Phase III
programme, which included more than 8,000 patients. The OLYMPUS,
ALPS and ANDES trials evaluated roxadustat compared to placebo in
NDD patients. ROCKIES, SIERRAS and HIMALAYAS, evaluated roxadustat
compared to epoetin alfa in DD patients. HIMALAYAS evaluated
roxadustat compared to epoetin alfa in incident dialysis (ID)
patients; there were ID patients in ROCKIES and
SIERRAS.
AstraZeneca in CVRM
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.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) 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 & Immunology. Based in Cambridge, UK, AstraZeneca
operates in over 100 countries and its innovative medicines are
used by millions of patients worldwide. Please
visit astrazeneca.com and
follow the Company on Twitter @AstraZeneca.
Contacts
For details on how to contact the Investor Relations Team, please
click here.
For Media contacts, click here.
References
1.
National Institute of Diabetes and Digestive and Kidney Diseases.
Anemia in Chronic Kidney Disease; 2014 [cited 10 December 2020].
Available from: URL:
https://www.niddk.nih.gov/health-information/kidney-disease/anemia.
2. Babitt JL, Lin HY. Mechanisms of
Anemia in CKD. J Am Soc
Nephrol (2012);
23:1631-1634.
3. KDOQI Clinical Practice Guidelines
and Clinical Practice Recommendations for Anaemia in Chronic Kidney
Disease. Am J Kidney
Dis. 2006 May; 47(5):
S1-S132.
4. Bikbov B et al. Global, regional,
and national burden of chronic kidney disease, 1990-2017: A
systematic analysis for the Global Burden of Disease Study
2017. The Lancet 2020; 395(10225):709-33.
Adrian Kemp
Company Secretary
AstraZeneca PLC
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 December
2020
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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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