AstraZeneca PLC Roxadustat approved in China for the treatment of (8927J)
22 Agosto 2019 - 8:01AM
UK Regulatory
TIDMAZN
RNS Number : 8927J
AstraZeneca PLC
22 August 2019
22 August 2019 07:00 BST
Roxadustat approved in China for the treatment of anaemia in
non-dialysis-dependent patients with chronic kidney disease
China is the first country to approve roxadustat for all
chronic kidney disease patients with anaemia
AstraZeneca today announced that its partner FibroGen (China)
Medical Technology Development Co., Ltd. (FibroGen China) has
received marketing authorisation for roxadustat in China for the
treatment of anaemia caused by chronic kidney disease (CKD) in
non-dialysis-dependent (NDD) patients.
This approval, granted by the National Medical Products
Administration, is primarily supported by a Phase III trial in
NDD-CKD patients with anaemia, in which roxadustat demonstrated a
statistically-significant improvement in haemoglobin levels from
baseline averaged over weeks seven to nine of treatment, with a
mean change of 1.9 g/dL compared to -0.4 g/dL with placebo. This
data was published in The New England Journal of Medicine in July
2019.
This marketing authorisation follows the approval of roxadustat
in China in December 2018 for anaemia in CKD patients who are on
dialysis. AstraZeneca and FibroGen China expect to launch
roxadustat in China during the second half of 2019.
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "With this approval for roxadustat in China, we are
now able to provide this first-in-class medicine to all patients
living with chronic kidney disease who experience anaemia,
regardless of whether they require dialysis. This is a significant
milestone and we look forward to bringing the medicine to patients
later this year."
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 risk of death in
patients with CKD.(1) Anaemia becomes increasingly common in
patients with CKD as their disease progresses.(1)
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 and not on dialysis.
Roxadustat is a hypoxia-inducible factor prolyl hydroxylase
inhibitor 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.
About the AstraZeneca and FibroGen China collaboration
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.
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 AstraZeneca in CV, renal and metabolism (CVRM)
CVRM together form one of AstraZeneca's main therapy areas and 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 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, CVRM 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.
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