TIDMAZN
RNS Number : 4523F
AstraZeneca PLC
16 July 2021
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
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