TIDMGSK
RNS Number : 5026I
GlaxoSmithKline PLC
19 April 2022
Issued: 19 April 2022, London UK
US Food and Drug Administration accepts New Drug Application for
daprodustat
-- Regulatory 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 primary
efficacy and safety endpoints in non-dialysis and dialysis
patients
-- US FDA regulatory submission acceptance is the third major
regulatory milestone for daprodustat following the European
Medicines Agency (EMA) regulatory submission acceptance and
approval of Duvroq in Japan
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the US
Food and Drug Administration (FDA) accepted the New Drug
Application (NDA) for daprodustat, an oral hypoxia-inducible factor
prolyl hydroxylase inhibitor (HIF-PHI), for the potential 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 FDA has assigned a Prescription Drug User Fee Act
(PDUFA) action date of 1 February 2023.
The daprodustat NDA is based on positive results from the ASCEND
phase III clinical trial programme, which included five pivotal
trials assessing the efficacy and safety of daprodustat for the
treatment of anaemia across the spectrum of CKD. Results from the
key cardiovascular outcomes trials were published in the New
England Journal of Medicine in November 2021 and included
non-dialysis ( ASCEND-ND ) and dialysis ( ASCEND-D ) CKD patients.
These trials demonstrated that daprodustat improved and/or
maintained haemoglobin (Hb) within the target level (10-11.5 g/dL)
without increased major adverse cardiovascular events (MACE) in the
intention-to-treat (ITT) populations in each pivotal study, when
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. In March 2022 , the European Medicines
Agency (EMA) validated the marketing authorisation application
(MAA) for daprodustat, which is currently under review. Additional
regulatory filings are anticipated to continue throughout 2022.
About the ASCEND phase III clinical trial programme
The ASCEND programme includes five phase III trials to assess
the efficacy and safety profile of daprodustat for treating anaemia
of CKD across the disease pathway. The programme enrolled over
8,000 patients 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 two pivotal cardiovascular outcomes trials,
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]) :
-- 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 the
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 of the trial.
The trial met its primary efficacy and safety endpoints. Results
showed that daprodustat improved and/or maintained Hb within the
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 trial.
The trial 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 Over 700 million patients suffer from CKD
worldwide, and an estimated 1-in-7 of these patients have anaemia.
[v](, [vi]) 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 potential 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
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information please visit www.gsk.com/about-us .
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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 2021, and any impacts of the
COVID-19 pandemic.
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[i] Singh A, et al. Daprodustat for the Treatment of Anemia in
Patients Not Undergoing Dialysis. N Engl J Med. 2021;
385:2313-2324.
[ii] Singh A, et al. Daprodustat for the Treatment of Anemia in
Patients Undergoing Dialysis. N Engl J Med. 2021;385:2325-2335.
[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.
[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.
[v] 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. .
[vi] Stauffer ME, Fan T. Prevalence of anemia in chronic kidney
disease in the United States. PLoS One. 2014;9(1):e84943.
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