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 June 2020
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 . . . . . . . .
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by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1): ____
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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 ASCEND-D and ASCEND-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:
●
ASCEND-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.
●
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 ESAs 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, 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.
GSK enquiries:
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UK
Media enquiries:
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Simon
Steel
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+44 (0)
20 8047 5502
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(London)
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Tim
Foley
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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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Kristen
Neese
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+1 804
217 8147
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(Philadelphia)
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Kathleen
Quinn
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+1 202
603 5003
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(Washington
DC)
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Lyndsay
Meyer
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+1 202
302 4595
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(Washington
DC)
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Analyst/Investor
enquiries:
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Sarah
Elton-Farr
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+44 (0)
20 8047 5194
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(London)
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Danielle
Smith
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+44 (0)
20 8047 0932
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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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Frannie
DeFranco
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+1 215
751 4855
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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
"Risk Factors" in the company's Annual Report on Form 20-F for 2019
and any impacts of the COVID-19 pandemic.
Registered
in England & Wales:
No. 3888792
Registered
Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
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: June
29, 2020
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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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