TIDMAZN
RNS Number : 7800Q
AstraZeneca PLC
02 March 2021
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
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