REG - GSK PLC - GSK announces FDA meeting outcome on daprodustat

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27/10/2022 07:16

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RNS Number : 2668E  GSK PLC  27 October 2022

Issued: 26 October 2022, London UK

 

 

GSK reports outcome from US FDA Advisory Committee meeting on daprodustat for
anaemia of CKD

 

 

GSK plc (LSE/NYSE: GSK) today reports that the US Food and Drug Administration
(FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) supported that
the benefit of treatment with daprodustat outweighs the risks for adult
dialysis patients with anaemia of chronic kidney disease (CKD) with a 13 to 3
vote. In adult non-dialysis patients with anaemia of CKD, the CRDAC did not
support that the benefit of treatment with daprodustat outweighs the risks
with a 5 to 11 vote.

 

The US FDA will consider the vote, feedback, and recommendations from the
CRDAC as it reviews the New Drug Application (NDA) and is not bound by the
Committee's recommendation. The CRDAC provides the US FDA with independent,
expert advice and reviews and evaluates available data concerning the safety
and efficacy of marketed and potential new medicines for use in the treatment
of cardiovascular and renal disorders. In April 2022
(https://www.gsk.com/en-gb/media/press-releases/us-food-and-drug-administration-accepts-new-drug-application-for-daprodustat/)
, the US FDA accepted the NDA for daprodustat and assigned a Prescription Drug
User Fee Act date of 1 February 2023.

 

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. 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. There
remains an unmet need for convenient treatment options with efficacy and
safety comparable to current treatments.

 

Chris Corsico, Senior Vice President, Development, GSK, said: "Today's robust
discussion was an important step in the review of daprodustat. We are pleased
the committee recognised the potential for daprodustat to help certain
patients who are living with anaemia of CKD given limited treatment options.
We want to thank the physicians, patients and advocacy community who shared
their valuable insights about this disease. We look forward to continuing to
work with the US FDA as they complete their review of our new drug
application."

 

Daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor
(HIF-PHI), was studied in 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. All five pivotal
trials met the primary endpoints. Results from two trials were published in
the New England Journal of Medicine in November 2021, which 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. Additional results were also published in the New England
Journal of Medicine supplementary appendix, which included non-dialysis
(ASCEND-ND
(https://www.nejm.org/doi/suppl/10.1056/NEJMoa2113380/suppl_file/nejmoa2113380_appendix.pdf)
) and dialysis (ASCEND-D
(https://www.nejm.org/doi/suppl/10.1056/NEJMoa2113379/suppl_file/nejmoa2113379_appendix.pdf)
) CKD patients.

 

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, with
a regulatory decision anticipated in the first half of 2023. 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. Duvroq
is the market leader and preferred HIF-PHI in Japan.

 

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 the treatment of anaemia of CKD across the
disease spectrum. 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 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 trial. The trial met its primary efficacy and safety endpoints. Results
showed that daprodustat improved and/or maintained haemoglobin (Hb) within the
target level (10-11.5 g/dL) for these patients, and the primary safety
analysis of the intention-to-treat (ITT) population showed that daprodustat
achieved non-inferiority of major adverse cardiovascular events (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 trial.
The trial 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.

 

Additional results were also published in the New England Journal of Medicine
supplementary appendix, which included non-dialysis (ASCEND-ND
(https://www.nejm.org/doi/suppl/10.1056/NEJMoa2113380/suppl_file/nejmoa2113380_appendix.pdf)
) and 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, 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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GSK cautions investors that any forward-looking statements or projections made
by GSK, including those made in this announcement, are subject to risks and
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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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