TIDMGSK
RNS Number : 3487R
GlaxoSmithKline PLC
29 June 2020
Issued: 29 June 2020, London UK - LSE announcement
GSK receives first regulatory approval for Duvroq (daprodustat)
in Japan for patients with anaemia due to chronic kidney
disease
-- Approval marks a significant step in GSK's global efforts to
help patients with anaemia due to chronic kidney disease (CKD).
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced the approval
of a Japanese New Drug Application (JNDA) by the Ministry of
Health, Labour and Welfare for Duvroq (daprodustat) tablets, an
oral hypoxia-inducible factor prolyl hydroxylase inhibitor
(HIF-PHI), for the treatment of patients with anaemia due to
chronic kidney disease (CKD).
Dr. Hal Barron, Chief Scientific Officer and President R&D,
GSK, said: "The approval of Duvroq brings a new, convenient oral
treatment option to nearly 3.5 million patients in Japan who have
anaemia associated with renal disease. We are pleased with this
first approval and look forward to sharing data from our ongoing
phase III programme as we seek to help many more patients suffering
with this disease around the world."
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 encourages the
bone marrow to make more red blood cells and so reduce anaemia,
thereby benefitting patients.
The JNDA was primarily based on positive data from the phase III
programme conducted in Japan. The studies evaluated Duvroq for the
treatment of anaemia in patients across the spectrum of CKD from
stages 3-5. This included patients on dialysis, including both
hemo- and peritoneal dialysis, and those not on dialysis,
regardless of prior anaemia treatment with
erythropoiesis-stimulating agents (ESAs). In contrast to current
standard of care in patients with CKD which requires injections,
Duvroq offers convenience with oral administration and flexibility
with once-daily dosing for dialysis and non-dialysis patients.
Daprodustat is currently not approved as a treatment for anaemia
due to CKD or any other indication anywhere else in the world other
than in Japan. The ongoing phase III global programme, which
includes two cardiovascular outcome studies ASC-D and ASC-ND , will
support additional regulatory submissions across the world.
Duvroq is one of the medicines in GSK's growing portfolio of
innovative specialty care products. In Japan, Duvroq will be
exclusively distributed by Kyowa Kirin Co., Ltd. (KKC), following
the strategic commercialisation deal announced in 2018. KKC has
strong established expertise and experience in the treatment of
anaemia due to CKD to ensure availability of this innovative
medicine to patients. Commercial promotional launch activities will
be led by KKC. GSK will support scientific engagement through
medical science liaisons.
About the Japan clinical development programme
The three phase III 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 III registration programme,
including:
-- ASC-D (Anaemia Studies in CKD: Erythropoiesis via a Novel PHI
Daprodustat-Dialysis) enrolled approximately 3,000 dialysis
dependent patients with anaemia associated with CKD switching from
an ESA. Recruitment has completed.
-- ASC-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 ESAs on these endpoints as the
primary analysis. I f non-inferiority of the primary analysis is
met, superiority will be assessed for the MACE endpoint.
About daprodustat
Daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase
inhibitor, belongs to a new class of oral medicine indicated for
the treatment of anaemia due to chronic kidney disease in adult
patients not on dialysis and on dialysis. 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.
The Japanese Prescribing Information includes the following:
Serious thromboembolism such as cerebral infarction, myocardial
infarction and pulmonary embolism
may occur during the treatment with daprodustat, sometimes
resulting in death.
Significant Adverse Reactions:
Thromboembolism (0.8%). Thromboembolism such as Cerebral
infarction (0.3%), Pulmonary
embolism (0.3%), Retinal vein occlusion (0.3%), Deep vein
thrombosis (0.3%) or Vascular access
thrombosis (such as Shunt occlusion) (Frequency unknown).
For additional safety information refer to
www.ClinicalTrials.gov .
About anaemia due to chronic kidney disease.
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.(1) a
Anaemia due to chronic kidney disease commonly arises in
patients with kidney impairment because the kidneys no longer
produce sufficient amount of erythropoietin. The incidence of
anaemia due to chronic kidney disease 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) It is estimated that
CKD affects 1 in 10 people worldwide and was responsible for over
one million deaths in 2017.(4,5) Many of these CKD patients will
develop anaemia.
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;13(6):621-30.
https://doi.org/10.1007/s10157-009-0199-x
4. Hill NR et al. Global Prevalence of Chronic Kidney Disease -
A Systematic Review and Meta-Analysis. Plos One. 2016.
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0158765#authcontrib
5. GBD Chronic Kidney Disease Collaboration. Global, regional,
and national burden of chronic kidney disease, 1990-2017: a
systemic analysis for the Global Burden of Disease Study 2017. The
Lancet. Volume 395, Issue 10225, p709-733; February 29, 2020.
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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
"Risk Factors" in the company's Annual Report on Form 20-F for 2019
and any impacts of the COVID-19 pandemic.
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