a1058d
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 March 2022
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
as permitted by Regulation S-T Rule 101(b)(7): ____
Issued: 1 March 2022, London UK
European Medicines Agency (EMA) accepts marketing authorisation
application for daprodustat
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Submission for the treatment of
anaemia of chronic kidney disease based on the ASCEND Phase III
clinical trial programme, consisting of five trials that all met
their co-primary efficacy and safety endpoints
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EMA file acceptance is the first major
regulatory milestone for daprodustat since the approval of Duvroq
in Japan
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the
European Medicines Agency (EMA) validated the marketing
authorisation application (MAA) for daprodustat, an investigational
oral hypoxia-inducible factor prolyl hydroxylase inhibitor
(HIF-PHI), for the treatment of patients with anaemia of chronic
kidney disease (CKD). Daprodustat was developed based upon the
unique Nobel Prize-winning science that demonstrated how cells
sense and adapt to oxygen availability.
The MAA includes positive data from the ASCEND Phase III clinical
trial programme, which included five pivotal studies assessing
the efficacy and safety of daprodustat for the treatment of anaemia
across the course of CKD. Results from the key cardiovascular
outcomes studies were published in the New England Journal of
Medicine in November 2021
and included non-dialysis (ASCEND-ND)
and dialysis (ASCEND-D)
patients. These studies demonstrated that daprodustat improved
and/or maintained haemoglobin (Hb) within target level
(10-11.5 g/dL) without increased major adverse cardiovascular
events (MACE) in the intention-to-treat populations in each pivotal
study, compared to the standard of care, an erythropoietin
stimulating agent (ESA), across both non-dialysis and dialysis
patient settings.
Daprodustat is currently approved in Japan as Duvroq for patients
with renal anaemia. The submission to the EMA is the first major
regulatory milestone since the approval of Duvroq in Japan in 2020.
Regulatory filings are anticipated to continue throughout 2022 with
health authorities worldwide.
About the ASCEND Phase III clinical trial programme
The ASCEND programme includes five Phase III studies to assess the
efficacy and safety profile of daprodustat for the treatment of
anaemia of CKD across the disease pathway. The programme enrolled
over 8,000 patients who were treated for up to 4.26 years. Results
from all five studies were presented at the American Society of
Nephrology's Kidney Week 2021.
Results from the two pivotal cardiovascular outcomes studies,
ASCEND-ND and ASCEND-D, which investigated patients not on dialysis
and on dialysis, respectively, were also published in
the New England Journal of
Medicine[i],[ii]:
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ASCEND-ND (Anaemia
Studies in CKD: Erythropoiesis via a Novel PHI
Daprodustat-Non-Dialysis) enrolled 3,872 non-dialysis
dependent patients with anaemia of CKD who were either switched
from standard of care (ESA) or not currently receiving ESA therapy
to receive daprodustat or ESA control (darbepoetin alfa). Iron
management protocols were instituted across both arms in the study.
The study met its primary efficacy and safety endpoints. Results
showed daprodustat improved and/or maintained Hb within target
level (10-11.5 g/dL) for these patients, and the primary safety
analysis of the ITT population showed that daprodustat achieved
non-inferiority of MACE compared to ESA
control.
●
ASCEND-D (Anaemia
Studies in CKD: Erythropoiesis via a Novel PHI
Daprodustat-Dialysis) enrolled 2,964 dialysis patients with anaemia
of CKD who were switched to receive daprodustat or ESA control
from a standard of care ESA therapy. A uniform iron management
protocol was instituted across both arms of the study. The study
met its primary efficacy and safety endpoints. Results showed
daprodustat improved or maintained Hb within target levels (10-11.5
g/dL) for these patients, and the primary safety analysis of the
ITT population showed that daprodustat achieved non-inferiority of
MACE compared to ESA control.
About
anaemia of chronic kidney disease
CKD, characterised by progressive loss of kidney function, is an
increasing global public health burden.[iii] Risk
factors for CKD include hypertension, diabetes, obesity and primary
renal disorders.iii Furthermore,
CKD is an independent risk factor for cardiovascular
disease.iii Anaemia
is an important and frequent complication of
CKD.[iv] However,
it is often poorly diagnosed and undertreated in patients with
early-stage CKD, such as those not on dialysis.iv When
left untreated or undertreated, anaemia of CKD is associated with
poor clinical outcomes and leads to a substantial burden on
patients and healthcare systems.iv
About daprodustat
Daprodustat, a HIF-PHI, belongs to a novel class of oral medicines
indicated for the treatment of anaemia of CKD 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 correction of
anaemia, similar to the physiological effects that occur in the
human body at high altitude. Daprodustat has been developed to
provide a convenient oral treatment option for patients with
anaemia of CKD.
About GSK
GSK is a science-led global healthcare company. For further
information please visit www.gsk.com/about-us.
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GSK enquiries:
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Media
enquiries:
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Tim
Foley
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20 8047 5502
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(London)
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Madeleine
Breckon
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+44 (0)
20 8047 5502
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(London)
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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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Analyst/Investor
enquiries:
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Nick
Stone
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+44 (0)
7717 618834
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(London)
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Sonya
Ghobrial
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+44 (0)
7392 784784
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(Consumer)
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James
Dodwell
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+44 (0)
20 8047 2406
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(London)
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Mick
Readey
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+44 (0)
7990 339653
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(London)
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Jeff
McLaughlin
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+1 215
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Frannie
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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 in the Company's
Annual Report on Form 20-F for 2020, GSK's Q4 Results and any
impacts of the COVID-19 pandemic.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
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[1] Singh A, et al.
Daprodustat for the Treatment of Anemia in Patients Not Undergoing
Dialysis. N Engl J
Med. 2021;
385:2313-2324.
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1 Singh A, et al.
Daprodustat for the Treatment of Anemia in Patients Undergoing
Dialysis. N Engl J
Med.
2021;385:2325-2335.
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[1]iii Hill NR,
Fatoba ST, Oke JL, et al. Global prevalence of chronic kidney
disease - A systematic review and meta-analysis. PLoS One.
2016;11(7):e0158765.
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iv St Peter WL, Guo H, Kabadi S, et al. Prevalence,
treatment patterns, and healthcare resource utilization in Medicare
and commercially insured non-dialysis-dependent chronic kidney
disease patients with and without anemia in the United
States. BMC
Nephrol.
2018;19(1):67.
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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: March
01, 2022
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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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