a8139d
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 2023
Commission
File Number 001-15170
GSK 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 . . . . . . . .
Issued: 26 June 2023, London UK
GSK receives positive CHMP opinion recommending authorisation of
daprodustat for symptomatic anaemia associated with chronic kidney
disease in adults on chronic maintenance dialysis
GSK plc (LSE/NYSE: GSK) today announced that the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency has issued a positive opinion recommending authorisation of
daprodustat, an
oral hypoxia-inducible factor prolyl hydroxylase inhibitor
(HIF-PHI), for the treatment of
symptomatic anaemia associated with chronic kidney disease
(CKD) in adults
on chronic maintenance dialysis.
The positive CHMP opinion is based on data from three global phase
III trials in dialysis patients from the ASCEND clinical trial
programme, including ASCEND-D, which is a non-inferiority trial
that assessed the efficacy and safety of daprodustat for the
treatment of anaemia of CKD in adult patients on dialysis with a
comparator of a standard of care
erythropoiesis-stimulating agent (ESA) therapy.
Results (https://www.nejm.org/doi/full/10.1056/NEJMoa2113379?query=featured_home) from
ASCEND-D were published in the New England
Journal of Medicine in November 2021 with
additional results published in the New England
Journal of Medicine supplementary appendix,
which included dialysis (ASCEND-D) (https://www.nejm.org/doi/suppl/10.1056/NEJMoa2113379/suppl_file/nejmoa2113379_appendix.pdf) CKD
patients. Data from two additional trials in the ASCEND clinical
trial programme included incident dialysis (ID) patients
(ASCEND-ID) (https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2790862),
which were published in the Journal of
the American Medical Association (JAMA) Internal
Medicine in April 2022, and
three-times weekly dosing in dialysis patients
(ASCEND-TD) (https://journals.lww.com/cjasn/Fulltext/2022/09000/Three_Times_Weekly_Dosing_of_Daprodustat_versus.11.aspx), which
were published in the Clinical
Journal of the American Society of Nephrology
(CJASN) in September
2022.
CKD is an increasing global health burden affecting 700 million
patients worldwide, with an estimated one in seven patients also
developing anaemia, resulting in increased morbidity, mortality and
reduced quality of life.[1],[2],[3]
When not adequately managed in certain patients, it can result in
exhaustion and limit the ability to function in day-to-day life.
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.[4] There
is an unmet need for convenient treatment options with efficacy and
safety comparable to current treatments.
About daprodustat
Daprodustat, a HIF-PHI, belongs to a novel class of oral medicines
being studied 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.[5],[6] Daprodustat
is being developed to provide a convenient oral treatment option
for patients with anaemia of CKD.
In February
2023 (https://www.gsk.com/en-gb/media/press-releases/jesduvroq-daprodustat-approved-by-us-fda-for-anaemia-of-chronic-kidney-disease-in-adults-on-dialysis/), the
US Food and Drug Administration (FDA)
approved Jesduvroq (daprodustat) tablets for the once-a-day
treatment of anaemia due to CKD in adults who have been receiving
dialysis for at least four months. In
June 2020
(https://www.gsk.com/en-gb/media/press-releases/gsk-receives-first-regulatory-approval-for-duvroq-daprodustat-in-japan-for-patients-with-anaemia-due-to-chronic-kidney-disease/), Duvroq (daprodustat)
tablets were approved by Japan's Ministry of Health, Labour and
Welfare for the treatment of patients with anaemia of CKD not on
dialysis and on dialysis. Duvroq is the market leading and preferred HIF-PHI
in Japan.
About the ASCEND phase III clinical trial programme
The ASCEND programme included five Phase III trials to assess the
efficacy and safety profile of daprodustat for the treatment of
anaemia of CKD across the disease spectrum. The programme enrolled
over 8,000 patients who were treated for up to 4.26 years. Results
from all five trials were presented at the American Society of
Nephrology's Kidney Week 2021. Results from the pivotal
cardiovascular outcomes trial, ASCEND-D, which investigated
patients on dialysis, were published in
the New
England Journal of Medicine:[7]
● ASCEND-D (Anaemia
Studies in CKD: Erythropoiesis via a Novel PHI
Daprodustat-Dialysis)
(https://www.nejm.org/doi/full/10.1056/NEJMoa2113379?query=featured_home)
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 trial.
The trial met its primary efficacy (95%
confidence interval [CI], 0.12 to 0.24) and
safety endpoints (hazard
ratio, 0.93; 95% CI, 0.81 to 1.07). Results showed that 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.
Additional results
(https://www.nejm.org/doi/suppl/10.1056/NEJMoa2113379/suppl_file/nejmoa2113379_appendix.pdf)
were also published in the New
England Journal of Medicine supplementary
appendix, which included dialysis (ASCEND-D)
(https://www.nejm.org/doi/suppl/10.1056/NEJMoa2113379/suppl_file/nejmoa2113379_appendix.pdf)
CKD patients.
About anaemia of chronic kidney disease
CKD is characterised by progressive loss of kidney function.
Anaemia is an important and frequent complication of CKD and is
associated with increased
morbidity, mortality and reduced quality of life. It is often
poorly diagnosed and undertreated in patients with early-stage
CKD.[8] Over
700 million patients suffer from CKD worldwide, and an estimated
1-in-7 of these patients have anaemia.1,2 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.4
About GSK
GSK is a global biopharma company with a purpose to unite science,
technology, and talent to get ahead of disease together. Find out
more at (https://www.gsk.com/en-gb/).
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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
2022, and Q1 Results for 2023 and any impacts of the COVID-19
pandemic.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
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Middlesex
TW8
9GS
[1] Bikbov
B, Purcell CA, Levey AS, et al. Global, regional, and national
burden of chronic kidney disease, 1990-2017: a systematic analysis
for the Global Burden of Disease Study 2017. Lancet.
2020;395(10225):709-733.
[2] Stauffer
et al. Prevalence of anemia in chronic kidney disease in the United
States. PLoS One. 2014;9(1):e84943.
[3] Palaka
E, et al. The Impact of CKD Anaemia on Patients: Incidence, Risk
Factors, and Clinical Outcomes-A Systematic Literature Review. Int
J Nephrol. 2020 Jul 1;2020:769;2376
[4] Hanna
RM et al. Burden of anemia in chronic kidney disease: beyond
erythropoietin. Adv Ther. 2021;38(1):52-75.
[5] Ariazi
JL, Duffy KJ, Adams DF, et al. Discovery and preclinical
characterization of GSK1278863 (daprodustat), a small molecule
hypoxia inducible factor-prolyl hydroxylase inhibitor for anemia. J
Pharmacol Exp Ther. 2017;363(3):336-347.
[6] Maxwell
PH, Eckardt KU. HIF prolyl hydroxylase inhibitors for the treatment
of renal anaemia and beyond. Nat Rev Nephrol.
2016;12(3):157-168.
[7] Singh
A, et al. Daprodustat for the Treatment of Anemia in Patients
Undergoing Dialysis. N Engl J Med. 2021;
385:2325-2335.
[8] 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.
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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GSK plc
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(Registrant)
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Date: June
26, 2023
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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 GSK plc
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