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 March 2021
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.
Further update on
US regulatory review of roxadustat in anaemia of chronic kidney
disease
This announcement contains inside information
2 March 2021 07:00 GMT
Further update on US regulatory review of
roxadustat in anaemia of chronic kidney disease
AstraZeneca and FibroGen, Inc. (FibroGen) today announced
that the US Food and Drug Administration (FDA) informed
FibroGen that it will convene a meeting of the Cardiovascular and
Renal Drugs Advisory Committee to review the new drug application
for roxadustat. Roxadustat is under regulatory review for the
treatment of anaemia of chronic kidney disease (CKD).
AstraZeneca and FibroGen are committed to working with the FDA
ahead of the meeting and to bringing roxadustat to patients with
anaemia of CKD. A date for the advisory committee
meeting has not been determined.
The efficacy and safety of roxadustat, an oral hypoxia-inducible
factor prolyl hydroxylase (HIF-PH) inhibitor, have been
demonstrated in the pivotal Phase III programme including more than
8,000 patients and published in five peer-reviewed
journals.
Roxadustat is approved in China, Japan and Chile for the treatment
of anaemia in CKD in non-dialysis dependent (NDD) and
dialysis-dependent (DD) adult patients, and is under regulatory
review in the EU and other jurisdictions.
Anaemia
Anaemia can be a serious medical condition in which patients have
insufficient red blood cells (RBCs) and low haemoglobin levels, 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, 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 treatments called
HIF-PH inhibitors that promotes erythropoiesis, or red blood cell
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 (under the name Evrenzo), and Chile 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
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 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.
Phase III programme
The Phase III programme included more than 8,000 patients and was
conducted by AstraZeneca, FibroGen and Astellas.
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 and incident dialysis (ID)
patients. HIMALAYAS evaluated
roxadustat compared to epoetin alfa in ID patients; ROCKIES and
SIERRAS included ID patients.
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 the underlying
links between the heart, kidneys and pancreas more clearly,
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.
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:
02 March
2021
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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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