a4525f
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 July 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.
Status on US FDA
Advisory Committee for roxadustat
16 July 2021 07:00 BST
Status on FDA Advisory Committee vote on roxadustat in anaemia of
chronic kidney disease
The Food and Drug Administration's (FDA) Cardiovascular and Renal
Drugs Advisory Committee (CRDAC) has voted 13 to 1 that the
benefit-risk profile of roxadustat does not support approval for
the treatment of anaemia in chronic kidney disease (CKD) in
non-dialysis dependent (NDD) adult patients, and 12 to 2 that the
benefit-risk profile of roxadustat does not support approval for
the treatment of anaemia in CKD in dialysis-dependent (DD) adult
patients.
The FDA will consider the vote, independent opinions and
recommendations from experts as it reviews the new drug application
(NDA) and is not bound by the Committee's
recommendation.
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.
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "New solutions are needed for the six million people
in the US affected by anaemia of chronic kidney disease. Although
we are disappointed by today's outcome, we will continue to work
closely with our partner FibroGen and the FDA to determine the path
forward for roxadustat."
Earlier this year, the FDA
confirmed it would convene a meeting of the CRDAC to review the NDA
for roxadustat and requested further clarifying analyses of
clinical data to support the assessment. The FDA has not
announced when it will make its final decision for the roxadustat
NDA.
The CRDAC provides the FDA with independent, expert advice and
reviews and evaluates available data concerning the safety and
efficacy of marketed and potential new medicines for use in the
treatment of cardiovascular (CV) and renal
disorders.1
Roxadustat is approved in a number of countries, including China,
Japan, Chile and South Korea 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 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
and 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 three 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 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 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 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. US Food &
Drug Administration. Cardiovascular and Renal Drugs Advisory
Committee; 2021 [cited 2021 Jul 7]. Available from:
URL: https://www.fda.gov/advisory-committees/human-drug-advisory-committees/cardiovascular-and-renal-drugs-advisory-committee.
2. 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.
3. Babitt JL, et al. Mechanisms
of anemia in CKD. J Am Soc
Nephrol. 2012;
23:1631-1634.
4. Mayo Clinic.
Anemia; 2019 [cited 2021
Jul 7]. Available from: URL: https://www.mayoclinic.org/diseases-conditions/anemia/symptoms-causes/syc-20351360.
5. Mayo Clinic. Myelodysplastic
syndromes; 2021 [cited 2021 Jul 7]. Available from:
URL: https://www.mayoclinic.org/diseases-conditions/myelodysplastic-syndrome/symptoms-causes/syc-20366977.
6. 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.
7. 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:
16 July
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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