UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of August,
2019
Commission
File Number 001-15170
GlaxoSmithKline plc
(Translation
of registrant's name into English)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
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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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UK
Media enquiries:
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Simon
Moore
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+44 (0)
20 8047 5502
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(London)
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US
Media enquiries:
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Evan
Berland
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751 5497
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Courtney
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(Philadelphia)
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Analyst/Investor
enquiries:
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(London)
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Danielle
Smith
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+44 (0)
20 8047 2406
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(London)
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James
Dodwell
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+44 (0)
20 8047 2406
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(London)
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Jeff
McLaughlin
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+1 215
751 7002
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(Philadelphia)
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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
'Principal risks and uncertainties' in the company's Annual Report
on Form 20-F for 2018.
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Registered in England & Wales:
No. 3888792
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Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
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SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
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GlaxoSmithKline plc
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(Registrant)
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Date:
August
21, 2019
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By:/s/ VICTORIA
WHYTE
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GlaxoSmithKline plc
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