TIDMAZN
RNS Number : 7963K
AstraZeneca PLC
18 December 2018
18 December 2018 09:00 GMT
Roxadustat approved in China for the treatment of
anaemia in chronic kidney disease patients on dialysis
China is the first country to approve roxadustat
AstraZeneca today announced that its partner FibroGen (China)
Medical Technology Development Co., Ltd. (FibroGen China) has now
received formal marketing authorisation from the National Medical
Products Administration (NMPA) for roxadustat, a first-in-class
hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) and
new oral treatment for patients with anaemia caused by chronic
kidney disease (CKD) that are on dialysis. The medicine can be
prescribed to patients who use haemodialysis or peritoneal
dialysis.
Anaemia caused by CKD is associated with cardiovascular disease,
hospitalisation, cognitive impairment and reduced quality of life,
and has been shown consistently to increase the mortality risk in
patients with CKD.(1) Anaemia becomes increasingly common among
individuals with CKD as their disease progresses, affecting nearly
all patients at the dialysis stage.(1)
Sean Bohen, Executive Vice President, Global Medicines
Development and Chief Medical Officer, said: "Roxadustat is a
long-awaited, first-in-class medicine for patients with anaemia in
chronic kidney disease that are on dialysis. This first approval of
roxadustat in China is a significant step towards achieving our
ambition to transform care in a condition where prevalence in China
is increasing."
Roxadustat is the first approved oral HIF-PHI medicine for
patients with anaemia from CKD. This approval is supported by an
open-label, active-control 26-week Phase III trial in dialysis
dependent-CKD (DD CKD) patients with anaemia who were previously
treated with various forms of a generic erythropoiesis-stimulating
agent (ESA). In the trial, these DD-CKD patients were then
randomised to receive either roxadustat or epoetin alfa, an ESA.
Rates of adverse events related to roxadustat observed in the trial
were generally low (<5%), and mostly of Grade 1-2 severity. The
adverse events observed were consistent with underlying diseases in
patients with CKD.
Anaemia commonly develops in association with CKD and is
estimated to affect 120 million patients in China, with an
estimated 0.5 million patients on dialysis who may be suffering
from anaemia, a number that is increasing significantly.(2,3)
AstraZeneca and FibroGen China are collaborating on the
development and commercialisation of roxadustat in China. FibroGen
China, based in Beijing, is a wholly-owned subsidiary of FibroGen
Inc. that sponsored the development and registration of roxadustat.
FibroGen China conducted the China Phase III clinical trials and
submitted the New Drug Application for registration of roxadustat
to the Chinese regulatory authorities. Following this approval,
AstraZeneca will manage commercialisation activities in China, and
FibroGen China will manage commercial manufacturing and medical
affairs as well as continued clinical development and regulatory
affairs. AstraZeneca and FibroGen expect to launch roxadustat in
China during the second half of 2019.
About roxadustat
Roxadustat is a first-in-class, orally-administered small
molecule currently approved in China for the treatment of patients
with anaemia from CKD on dialysis. Roxadustat is a HIF-PHI that
promotes erythropoiesis by increasing endogenous production of
erythropoietin and improving iron regulation, and overcoming the
negative impact of inflammation on haemoglobin synthesis and red
blood cell production by downregulating hepcidin. Administration of
roxadustat has been shown to induce coordinated erythropoiesis,
increasing red blood cell count while maintaining plasma
erythropoietin levels within or near normal physiologic range, in
multiple subpopulations of CKD patients, including in the presence
of inflammation and without a need for supplemental intravenous
iron.
FibroGen, Inc., the originator, and AstraZeneca are
collaborating on the development and commercialisation of
roxadustat for the treatment of anaemia in patients with CKD in the
US, China, and other global markets. FibroGen and Astellas Pharma
Inc. are collaborating on the development and commercialisation of
roxadustat for the treatment of anaemia in patients with CKD in
territories including Japan, Europe, the Commonwealth of
Independent States, the Middle East, and South Africa.
About anaemia in CKD in China
Anaemia commonly develops in association with CKD and is linked
to significant morbidity and mortality in both the dialysis and
non-dialysis populations. CKD affects an estimated 120 million
patients in China.2 Although CKD may occur at any age, it is more
common in aging populations, and its prevalence is increasing. CKD
can be both a cause and a consequence of cardiovascular disease and
is a critical healthcare issue. There is no treatment available
that is curative or has the ability to stop kidney
deterioration.
About FibroGen
FibroGen, Inc., headquartered in San Francisco, California, with
subsidiary offices in Beijing and Shanghai, People's Republic of
China, is a leading biopharmaceutical company discovering and
developing a pipeline of first-in-class therapeutics. The company
applies its pioneering expertise in hypoxia-inducible factor (HIF),
connective tissue growth factor (CTGF) biology, and clinical
development to advance innovative medicines for the treatment of
anemia, fibrotic disease, and cancer. Roxadustat, the company's
most advanced product candidate, is an oral small molecule
inhibitor of HIF prolyl hydroxylase activity, completing worldwide
Phase 3 clinical development for the treatment of anemia in chronic
kidney disease (CKD), with a New Drug Application (NDA) now
approved by the National Medical Products Administration (NMPA) in
China. Our partner Astellas submitted a NDA for the treatment of
anemia in CKD patients on dialysis in Japan and currently under
review by the Pharmaceuticals and Medical Devices Agency (PMDA).
Roxadustat is in Phase 3 clinical development in the U.S. and
Europe and in Phase 2/3 development in China for anemia associated
with myelodysplastic syndromes (MDS). Pamrevlumab, an anti-CTGF
human monoclonal antibody, is advancing towards Phase 3 clinical
development for the treatment of idiopathic pulmonary fibrosis
(IPF) and pancreatic cancer, and is currently in a Phase 2 trial
for Duchenne muscular dystrophy (DMD). FibroGen is also developing
a biosynthetic cornea in China. For more information, please visit
www.fibrogen.com.
About AstraZeneca in Cardiovascular, Renal & Metabolism
(CVRM)
Cardiovascular, renal and metabolism together form one of
AstraZeneca's main therapy areas and key growth drivers. 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. Our 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.
About AstraZeneca
AstraZeneca 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. AstraZeneca operates in over 100
countries and its innovative medicines are used by millions of
patients worldwide. For more information, please visit
astrazeneca.com and follow us on Twitter @AstraZeneca.
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References
1. Babitt JL, Lin HY. Mechanisms of Anemia in CKD. J Am Soc Nephrol (2012); 23:1631-1634.
2. Zhang L, Wang F, Wang L, et al. Prevalence of chronic kidney
disease in China: a cross-sectional survey. Lancet 2012; 379:
815-22.
3. China National Renal Data System (CNRDS), 2016.
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