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 2021
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
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as permitted by Regulation S-T Rule 101(b)(7): ______
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contained in this Form is also thereby furnishing the information
to the Commission pursuant to Rule 12g3-2(b) under the Securities
Exchange Act of 1934.
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No X
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assigned to the Registrant in connection with Rule 12g3-2(b):
82-_____________
AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Update on US review
of roxadustat
11 August 2021 14:35 BST
Update on US regulatory review of roxadustat
in anaemia of chronic kidney disease
The US Food and Drug Administration (FDA) has issued a
complete response letter (CRL) regarding the New Drug Application
(NDA) for roxadustat for the treatment of anaemia of chronic kidney
disease (CKD), in both non-dialysis dependent (NDD) and
dialysis-dependent (DD) adult patients.
The CRL requested an additional clinical trial on the safety of
roxadustat in both the NDD and DD patient populations.
AstraZeneca is working with its partner FibroGen, Inc. (FibroGen)
and the FDA to evaluate next steps.
The safety and efficacy of roxadustat, an oral hypoxia-inducible
factor prolyl hydroxylase (HIF-PH) inhibitor, have been
demonstrated in the Phase III programme including more than 8,000
patients and published in five peer-reviewed journal
articles.
Roxadustat is approved in a number of countries, including China
and Japan, for the treatment of anaemia in CKD in NDD and DD adult
patients. It is under regulatory review in other jurisdictions,
including in the European Union, where it has recently received a
positive CHMP
opinion.
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 frequently causes significant fatigue, cognitive dysfunction
and decreased quality of life, and is associated with increased
risk of hospitalisation, CV complications and
death.1,2 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.2,3,4 CKD
affects 840 million patients worldwide and is generally
progressive, characterised by gradual loss of kidney function that
may eventually lead to kidney failure.5,6
Phase III programme
The Phase III programme included more than 8,000 patients and was
conducted by AstraZeneca, FibroGen and Astellas Pharma Inc.
(Astellas). The OLYMPUS, ALPS and ANDES trials
evaluated roxadustat compared to placebo in NDD-CKD patients.
ROCKIES, SIERRAS and HIMALAYAS evaluated roxadustat compared to
epoetin alfa in DD-CKD and incident
dialysis (ID) patients. HIMALAYAS evaluated
roxadustat compared to epoetin alfa in ID patients; ROCKIES and
SIERRAS included ID and prevalent dialysis
patients.
Roxadustat
Roxadustat,
an oral medicine, could be the first in a new class of treatments
called oral HIF-PH inhibitors that promotes erythropoiesis, or RBC
production, through increased endogenous production of
erythropoietin, improved iron absorption and mobilisation, and
reduction of hepcidin. Roxadustat is also in clinical development
for anaemia associated with MDS and for chemotherapy-induced
anaemia.
Roxadustat
is approved in China,
Japan, Chile and South Korea (under the name Evrenzo), for the treatment of anaemia
in CKD in NDD and 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 and accepted by the European Medicines Agency for review
in May 2020. It is under final regulatory review following a
positive EU CHMP opinion in June 2021.
AstraZeneca
and FibroGen are collaborating on the development and
commercialisation of roxadustat for the potential treatment of
anaemia in the US, China and other countries 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 Japan,
Europe, Turkey, Russia and the Commonwealth of Independent States,
the Middle East and South Africa.
AstraZeneca in CVRM
Cardiovascular, Renal and Metabolism (CVRM), part of
BioPharmaceuticals, forms one of AstraZeneca's main disease 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 for organ protection and improved 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 CV 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 in
Oncology, Rare Diseases, and BioPharmaceuticals, including
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 2021 Jul 7].
Available from: URL: https://www.niddk.nih.gov/health-information/kidney-disease/anemia.
|
2.
|
Babitt JL, et al. Mechanisms of anemia in CKD. J Am Soc
Nephrol. 2012;
23:1631-1634.
|
3.
|
Mayo Clinic. Anemia; 2019 [cited 2021 Jul 7].
Available from: URL: https://www.mayoclinic.org/diseases-conditions/anemia/symptoms-causes/syc-20351360.
|
4.
|
Mayo Clinic. Myelodysplastic syndromes; 2021 [cited 2021 Jul 7].
Available from: URL: https://www.mayoclinic.org/diseases-conditions/myelodysplastic-syndrome/symptoms-causes/syc-20366977.
|
5.
|
Jager KJ, et al. A single number for advocacy and
communication-worldwide more than 850 million individuals have
kidney diseases. Nephrol Dial
Transplant.
2019;34(11):1803-1805.
|
6.
|
Bikbov B et al. Global, regional, and national burden of chronic
kidney disease, 1990-2017: A systematic analysis for the Global
Burden of Disease Trial 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:
11 August 2021
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|
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