TIDMGSK
RNS Number : 7499J
GlaxoSmithKline PLC
21 August 2019
Issued: Wednesday 21 August 2019, London UK
GSK submits first regulatory application for daprodustat in
Japan for patients with renal anaemia due to chronic kidney
disease
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced the
submission of a Japanese New Drug Application (JNDA) to the
Ministry of Health, Labour and Welfare seeking marketing approval
for daprodustat, an oral hypoxia-inducible factor prolyl
hydroxylase inhibitor (HIF-PHI), for the treatment of patients with
renal anaemia due to chronic kidney disease (CKD).
Dr Hal Barron, Chief Scientific Officer and President R&D,
GSK said, "Around 3.5 million patients in Japan have anaemia
associated with renal disease which can result in weakness and
fatigue. We are excited about our first regulatory filing for
daprodustat which, if approved, will provide a new and convenient
oral treatment option for these patients."
Anaemia is common in patients with CKD because the kidneys no
longer produce adequate amounts of erythropoietin, a hormone
involved in prompting the production of red blood cells.(1)
HIF-PHIs are a new class of drug that trigger the body's
adaptations to hypoxia (i.e. oxygen deprivation) and encourage the
bone marrow to make more red blood cells, thereby benefitting
patients with renal anaemia.
The JNDA for daprodustat is primarily based on positive data
from the phase 3 programme conducted in Japan. The studies
evaluated daprodustat for the treatment of anaemia in patients
across the spectrum of CKD from stages 3-5. This included patients
on dialysis and those not on dialysis, regardless of prior anaemia
treatment with erythropoiesis-stimulating agents (ESAs).
Daprodustat is not approved as a treatment for renal anaemia or
any other indication anywhere in the world. If approved,
daprodustat will be exclusively distributed in Japan by Kyowa Kirin
Co., Ltd., following the strategic commercialisation deal announced
in 2018. Launch activities, including engagement of healthcare
professionals and commercial activities, are expected to be
conducted jointly by Kyowa Kirin and GSK.
About the Japan clinical development programme
The three phase 3 studies in Japan included:
-- A 52-week study of 271 haemodialysis patients using ESAs
prior to the study. It compared daprodustat versus darbepoetin
alpha.
-- A 52-week study of 299 patients with stage 3-5 CKD not on
dialysis, with or without prior use of ESA. It compared daprodustat
versus epoetin beta pegol. Additionally, it included a cohort of 56
patients on peritoneal dialysis who were all treated with
daprodustat.
-- A 24-week open label study of haemodialysis in 28 patients
who were not receiving ESAs at entry to the study and were all
treated with daprodustat.
About the global clinical development programme
GSK also has an ongoing global phase 3 registration programme,
including:
-- ASCEND-D (Anaemia Studies in CKD: Erythropoiesis via a Novel
PHI Daprodustat-Dialysis) will enrol approximately 3,000 dialysis
dependent patients with anaemia associated with CKD switching from
an ESA. Recruitment has completed.
-- ASCEND-ND (Anaemia Studies in CKD: Erythropoiesis via a Novel
PHI Daprodustat-Non-Dialysis) will enrol approximately 4,500
non-dialysis dependent patients with anaemia associated with CKD
and will include patients either switching from or naive to an ESA.
Recruitment remains ongoing.
For both studies, the co-primary endpoints are time to first
occurrence of major adverse cardiovascular events (MACE) and mean
change in haemoglobin between the baseline and efficacy period
(mean over weeks 28-52). The studies will assess whether
daprodustat is non-inferior to recombinant human erythropoietin and
its analogues on these endpoints as the primary analysis. If
non-inferiority of the primary analysis is met, superiority will be
assessed for the MACE endpoint.
About daprodustat
Daprodustat is an oral hypoxia-inducible factor prolyl
hydroxylase inhibitor. Inhibition of oxygen-sensing prolyl
hydroxylase enzymes stabilises hypoxia-inducible factors, which can
lead to transcription of erythropoietin and other genes involved in
the production of red blood cells and iron metabolism, similar to
the physiological effects that occur in the body at high altitude.
Daprodustat has been developed to provide an orally-convenient
treatment option which avoids the administration challenges and
cold storage requirements of injectable ESAs/recombinant human
erythropoietin.
About renal anaemia
Anaemia is the term used to describe a decrease of red blood
cells or haemoglobin concentration which carry oxygen to the body,
and in general, haemoglobin is used for diagnosis of anaemia.
Kidneys produce hormones including erythropoietin, which stimulates
red blood cell production. Renal anaemia commonly arises in
patients with kidney impairment because the kidneys no longer
produce sufficient amount of erythropoietin, a hormone involved in
prompting the production of red blood cells.(1) The incidence of
renal anaemia increases as kidney function declines. It is
estimated that
10.9 million patients in Japan have stages 3-5 CKD and of these,
32% have anaemia.(2, 3)
About GSK
GSK is a science-led global healthcare company with a special
purpose: to help people do more, feel better, live longer. For
further information please visit www.gsk.com/about-us/.
References
1. Anemia in Chronic Kidney Disease. National Institute of
Diabetes and Digestive and Kidney Diseases.
https://www.niddk.nih.gov/health-information/kidney-disease/anemia
2. Akizawa T. et al. Burden of Anemia in Chronic Kidney Disease
Patients in Japan: A Literature Review. Ther Apher Dial.
2018;22(5):444-56. https://doi.org/10.1111/1744-9987.12712
3. Imai E. et al. Prevalence of chronic kidney disease in the
Japanese general population. Clin Exp Nephrol. 2009
Dec;13(6):621-30. https://doi.org/10.1007/s10157-009-0199-x
GSK enquiries:
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5502
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enquiries: 5194
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2406
James Dodwell +44 (0) 20 8047 (London)
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Jeff McLaughlin +1 215 751 7002 (Philadelphia)
Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or
projections made by GSK, including those made in this announcement,
are subject to risks and uncertainties that may cause actual
results to differ materially from those projected. Such factors
include, but are not limited to, those described under Item
3.D 'Principal risks and uncertainties' in the company's Annual
Report on Form 20-F for 2018.
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