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 July 2021
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
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Issued: 16 July 2021, London UK - LSE announcement
GSK announces positive headline results from five Phase 3 studies
of daprodustat for patients with anaemia due to chronic kidney
disease
Full
results to be presented at a medical meeting later this year
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced positive
headline results from five studies of the Phase 3 ASCEND programme,
evaluating the efficacy and safety profile of daprodustat, an
investigational oral hypoxia-inducible factor prolyl hydroxylase
inhibitor (HIF-PHI), for patients with anaemia due to
chronic kidney disease (CKD).
The ASCEND programme showed that daprodustat met its primary
efficacy endpoint in each study, demonstrating an improvement in
haemoglobin (Hgb) levels in untreated patients and maintaining Hgb
levels in patients treated with an erythropoietin stimulating agent
(ESA), a standard treatment option, in patients with anaemia
of CKD. In addition, the key cardiovascular outcomes studies for
non-dialysis (ASCEND-ND) and dialysis patients (ASCEND-D)
demonstrated that daprodustat was non-inferior when compared
to an ESA in the risk of Major Adverse Cardiovascular
Events (MACE), the co-primary endpoint of both
studies.
Dr. Hal Barron, Chief Scientific Officer and President
R&D, GSK, said: "I am particularly pleased with the
results from the ASCEND-ND and ASCEND-D studies given the
importance of managing cardiovascular outcomes for patients who are
currently suffering from anaemia due to chronic kidney disease, as
well as the need to provide a convenient, oral treatment option. We
will continue to analyse the data from the robust phase 3 ASCEND
programme and look forward to working closely with regulators as we
plan for our submissions."
In addition to the ASCEND-D and ASCEND-ND studies, the programme
also included studies focused on incident dialysis, for patients
just starting dialysis (ASCEND-ID); quality of life measures
(ASCEND-NHQ); as well as three-times weekly dosing regimens
(ASCEND-TD). Each of the studies from the programme met its
respective primary or co-primary endpoint(s). The programme
enrolled over 8,000 patients who were treated for up to 3.75 years.
The full results of the studies will be presented at a forthcoming
medical meeting later this year and will be used to inform
regulatory pathways with health authorities worldwide.
Across the ASCEND programme, daprodustat was generally well
tolerated in both non-dialysis and dialysis patients. The
incidence of treatment-emergent adverse events was similar between
treatment groups and the nature of reported events was consistent
with the underlying patient population. The most commonly reported
adverse events in patients receiving daprodustat across the ASCEND
programme included hypertension, diarrhoea, dialysis hypotension,
peripheral edema, and urinary tract infection.
Daprodustat is currently approved in Japan as Duvroq for patients
with renal anaemia. It is not approved anywhere else in the
world.
About Anaemia of CKD
Chronic kidney disease, characterised by progressive loss of kidney
function, is an increasing global public health
burden.1 Risk
factors for CKD include hypertension, diabetes, obesity and primary
renal disorders.1 Furthermore,
CKD is an independent risk factor for cardiovascular
disease.1 Anaemia
is an important and frequent complication of
CKD.2 However,
it is often poorly diagnosed and undertreated in patients with
early stage CKD, such as those not on dialysis.2 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.2
About daprodustat
Daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase
inhibitor (HIF-PHI), belongs to a novel class of oral medicines
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 correction of
anaemia, similar to the physiological effects that occur in the
body at high altitude. Daprodustat has been developed to provide a
convenient oral treatment option for patients with anaemia
associated with CKD.
About GSK
GSK is a science-led global healthcare company. For further
information please visit www.gsk.com/about-us.
GSK enquiries:
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Media enquiries:
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Tim Foley
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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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James Dodwell
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+44 (0) 20 8047 2406
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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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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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+1 215 751 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 in the Company's Annual Report on Form
20-F for 2020 and any impacts of the COVID-19 pandemic.
Registered in England & Wales:
No.
3888792
Registered Office:
980 Great West
Road
Brentford,
Middlesex
TW8 9GS
References
[1] 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.
[2] 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.
Wong MMY, Tu C, Li Y, et al. Anemia and
iron deficiency among chronic kidney disease stages 3-5 ND
patients in the Chronic Kidney Disease Outcomes and Practice
Patterns Study: often unmeasured, variably
treated. Clin Kidney
J. 2019. doi:
10.1093/ckj/sfz091
Hoshino J, Muenz D, Zee J, et al. Associations of hemoglobin
levels with health-related quality of life, physical activity, and
clinical outcomes in persons with stage 3-5 nondialysis
CKD. J
Ren Nutr. 2020.
Toft G, Heide-Jorgensen U, van Haalen H, et al. Anemia and
clinical outcomes in patients with non-dialysis dependent or
dialysis dependent severe chronic kidney disease: a Danish
population-based study. J
Nephrol. 2020;33(1):147-156.
Locatelli F, Pisoni RL, Combe C, et al. Anaemia in
haemodialysis patients of five European countries: association with
morbidity and mortality in the Dialysis Outcomes and Practice
Patterns Study (DOPPS). Nephrol Dial
Transplant. 2004;19(1):121-132.
Hayashi T, Uemura Y, Kumagai M, et al. Effect of
achieved hemoglobin level on renal outcome in non-dialysis chronic
kidney disease (CKD) patients receiving epoetin beta pegol: MIRcerA
CLinical Evidence on Renal Survival in CKD patients with renal
anemia (MIRACLE-CKD Study). Clin Exp
Nephrol. 2019;23(3):349-361.
Walker AM, Schneider G, Yeaw J, et al. Anemia as a predictor
of cardiovascular events in patients with elevated serum
creatinine. J Am Soc
Nephrol. 2006;17(8):2293-2298.
Eriksson D, Goldsmith D, Teitsson S, et al. Cross-sectional
survey in CKD patients across Europe describing the association
between quality of life and anaemia. BMC
Nephrol. 2016;17(1):97.
van Haalen H, Jackson J, Spinowitz B, et al. Impact of
chronic kidney disease and anemia on health-related quality of life
and work productivity: analysis of multinational real-world
data. BMC
Nephrol. 2020;21(1):88.
Eriksson D, Teitsson S, Goldsmith D, et al. Cross-sectional
descriptive study of the impact of anaemia in patients with chronic
kidney disease on healthcare resource utilisation and work
productivity across Europe. Value
Health. 2015;18(A514).
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: July
16, 2021
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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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