REG - GSK PLC - GSK provides update on FDA review of daprodustat

GSKAnnouncement

06/09/2022 13:16

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RNS Number : 4697Y  GSK PLC  06 September 2022

Issued: 6 September 2022, London UK

 

GSK announces update on US FDA regulatory review of daprodustat in anaemia of
chronic kidney disease

 

 

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug
Administration (FDA) will convene a meeting of the Cardiovascular and Renal
Drugs Advisory Committee to review the New Drug Application (NDA) for
daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor
(HIF-PHI) under regulatory review for the potential treatment of anaemia due
to chronic kidney disease (CKD) in adult patients on dialysis and not on
dialysis.

 

GSK is committed to working closely with the US FDA to bring daprodustat to
appropriate patients with anaemia of CKD. A date for the Advisory Committee
meeting is set for 26 October 2022.

 

Chris Corsico, Senior Vice President, Development, GSK said: "We believe
daprodustat and the results demonstrated in the ASCEND clinical trial
programme have significant potential for patients living with anaemia of CKD
who currently do not have an oral treatment option. We look forward to
participating in the upcoming Advisory Committee meeting and working with the
US FDA to complete its assessment of daprodustat, with the goal of bringing
this innovative new treatment to appropriate patients in the US."

 

The daprodustat NDA is based on positive results 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
spectrum 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
(https://www.nejm.org/doi/full/10.1056/NEJMoa2113380?query=featured_home) )
and dialysis (ASCEND-D
(https://www.nejm.org/doi/full/10.1056/NEJMoa2113379?query=featured_home) )
CKD patients. These studies demonstrated that daprodustat improved and/or
maintained haemoglobin (Hb) within the target level (10-11.5 g/dL), and the
primary safety analysis of the intention-to-treat (ITT) populations showed
that daprodustat achieved non-inferiority of MACE (major adverse
cardiovascular events) compared to the standard of care, an erythropoietin
stimulating agent (ESA), across both non-dialysis and dialysis patient
settings.

 

In March 2022
(https://www.gsk.com/en-gb/media/press-releases/european-medicines-agency-ema-accepts-marketing-authorisation-application-for-daprodustat/)
, the European Medicines Agency validated the marketing authorisation
application for daprodustat, which is currently under regulatory review.
Additional regulatory submissions are anticipated to continue throughout 2022.
In June 2022, Duvroq (daprodustat) tablets were approved by Japan's Ministry
of Health, Labour and Welfare for patients with renal anaemia.

 

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 spectrum. 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 
(#_edn1) ))(,( ii  (#_edn2) )):

 

·      ASCEND-ND
(https://www.nejm.org/doi/full/10.1056/NEJMoa2113380?query=featured_home)
(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 study. The study 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
(https://www.nejm.org/doi/full/10.1056/NEJMoa2113379?query=featured_home)
(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 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.

 

About anaemia of chronic kidney disease

CKD, characterised by progressive loss of kidney function, is an increasing
global public health burden.(( iii  (#_edn3) )) 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  (#_edn4) )) 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 one in seven have anaemia.(( v  (#_edn5)
))(,)(( vi  (#_edn6) )) 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 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.
Daprodustat is being developed to provide a convenient oral treatment option
for patients with anaemia of CKD.

 

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
(https://www.gsk.com/en-gb/company/)

 

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tionary 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, GSK's Q2 Results for 2022
and any impacts of the COVID-19 pandemic.

 

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 i  (#_ednref1) Singh A, et al. Daprodustat for the Treatment of Anemia in
Patients Not Undergoing Dialysis. N Engl J Med. 2021; 385:2313-2324.

 ii  (#_ednref2) Singh A, et al. Daprodustat for the Treatment of Anemia in
Patients Undergoing Dialysis. N Engl J Med. 2021;385:2325-2335.

 iii  (#_ednref3)   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  (#_ednref4) 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  (#_ednref5) 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  (#_ednref6) 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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