TIDMGSK
RNS Number : 6652O
GSK PLC
02 February 2023
Issued: 2 February 2023, London UK
Jesduvroq (daprodustat) approved by US FDA for anaemia of
chronic kidney disease in adults on dialysis
-- Jesduvroq is the only oral HIF-PHI approved in the US,
offering adults on dialysis with anaemia of chronic kidney disease
a new oral treatment option
GSK plc (LSE/NYSE: GSK) today announced that the US Food and
Drug Administration (FDA) has approved Jesduvroq (daprodustat), an
oral hypoxia-inducible factor prolyl hydroxylase inhibitor
(HIF-PHI), for the once-a-day treatment of anaemia due to chronic
kidney disease (CKD) in adults who have been receiving dialysis for
at least four months. Jesduvroq is the first innovative medicine
for anaemia treatment in over 30 years and the only HIF-PHI
approved in the US, providing a new oral, convenient option for
patients in the US with anaemia of CKD on dialysis.
Tony Wood, President and Chief Scientific Officer, GSK, said:
"Over the last several decades, there has been little innovation in
anaemia of CKD. We are proud to have developed Jesduvroq as a new
oral treatment where there is a patient desire for more
options."
The FDA approval is based on results from the ASCEND-D trial,
assessing the efficacy and safety of Jesduvroq for the treatment of
anaemia of CKD in patients on dialysis. Results were published in
the New England Journal of Medicine with additional results
published in the New England Journal of Medicine supplementary
appendix.
CKD is an increasing global health burden affecting 700 million
patients worldwide, with an estimated one in seven patients also
developing 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. [3]
There is an unmet need for oral treatment options with efficacy and
safety comparable to current treatments.
LaVarne Burton, President and Chief Executive Officer, American
Kidney Fund, said: " Anaemia of CKD can be a debilitating condition
that is challenging to manage. This news means that patients on
dialysis who are living with anaemia of CKD now have another
treatment option to help manage their anaemia."
A marketing authorisation application for daprodustat is
currently under review with the European Medicines Agency, with a
regulatory decision anticipated in the first half of 2023. In June
2020 , daprodustat tablets were approved by Japan's Ministry of
Health, Labour and Welfare for the treatment of patients with
anaemia of CKD. In Japan, the brand name for daprodustat is Duvroq,
where it is the market leader and preferred HIF-PHI.
About Jesduvroq (daprodustat)
Jesduvroq , a HIF-PHI, belongs to a novel class of oral
medicines for the treatment of anaemia of CKD in adult patients 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. [4](, [5]) Jesduvroq
provides an oral treatment option for adult patients with anaemia
of CKD on dialysis. [6] Jesduvroq is a tablet available in 5 dosage
strengths: 1mg, 2mg, 4mg, 6mg, 8mg.
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:(6)
-- 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 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
daprodustatimproved 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 daprodustatachieved non-inferiority of
MACE compared to ESA control.
About anaemia of chronic kidney disease
CKD is characterised by progressive loss of kidney function. [7]
Anaemia is an important and frequent complication of CKD and is
associated with increased morbidity, mortality and reduced quality
of life. [8] It is often poorly diagnosed and undertreated in
patients with early-stage CKD. [9] Over 700 million patients suffer
from CKD worldwide, and an estimated 1-in-7 of these patients have
anaemia. (1) (,) (2) CKD affects approximately 39 million people in
the US, of whom approximately 6 million are also affected by
anaemia. (1) (,) (2) There are approximately 810,000 patients who
are end-stage renal disease (ESRD) in the US. [10] Of which, there
are 558,000 patients receiving dialysis. (10) Of these patients
receiving dialysis, 481,000 received hemodialysis and 77,000
received home or peritoneal dialysis. (10) 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. (3)
Please consult the full Prescribing Information including Boxed
Warning and Medication Guide.
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 gsk.com/company
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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 2021, GSK's Q4 Results for 2022 and
any impacts of the COVID-19 pandemic.
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[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] Hanna RM et al. Burden of anemia in chronic kidney disease:
beyond erythropoietin. Adv Ther. 2021;38(1):52-75.
[4] 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.
[5] Maxwell PH, Eckardt KU. HIF prolyl hydroxylase inhibitors
for the treatment of renal anaemia and beyond. Nat Rev Nephrol.
2016;12(3):157-168.
[6] Singh A, et al. Daprodustat for the Treatment of Anemia in
Patients Undergoing Dialysis. N Engl J Med. 2021;385:2325-2335.
[7] 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.
[8] 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
[9] 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.
[10] United States Renal Data System. 2022 USRDS Annual Data
Report: Epidemiology of kidney disease in the United States.
National Institutes of Health, National Institute of Diabetes and
Digestive and Kidney Diseases, Bethesda, MD, 2022. Available at:
https://usrds-adr.niddk.nih.gov/2022/end-stage-renal-disease/1-incidence-prevalence-patient-characteristics-and-treatment-modalities
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