a5070i
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 April 2022
Commission
File Number 001-15170
GlaxoSmithKline 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 . . . . . . . .
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ____
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
GSK is a science-led global healthcare company. For further
information please visit www.gsk.com/about-us.
|
GSK enquiries:
|
|
|
|
|
Media
enquiries:
|
Tim
Foley
|
+44 (0)
20 8047 5502
|
(London)
|
|
|
Dan
Smith
|
+44 (0)
20 8047 5502
|
(London)
|
|
|
Kristen
Neese
|
+1 804
217 8147
|
(Philadelphia)
|
|
|
Kathleen
Quinn
|
+1 202
603 5003
|
(Washington
DC)
|
|
|
Lyndsay
Meyer
|
+1 202
302 4595
|
(Washington
DC)
|
|
|
|
|
|
|
Analyst/Investor
enquiries:
|
Nick
Stone
|
+44 (0)
7717 618834
|
(London)
|
|
|
Sonya
Ghobrial
|
+44 (0)
7392 784784
|
(Consumer)
|
|
|
James
Dodwell
|
+44 (0)
20 8047 2406
|
(London)
|
|
|
Mick
Readey
|
+44 (0)
7990 339653
|
(London)
|
|
|
Josh
Williams
|
+44 (0)
7385 415719
|
(London)
|
|
|
Jeff
McLaughlin
|
+1 215
751 7002
|
(Philadelphia)
|
|
|
Frannie
DeFranco
|
+1 215
751 4855
|
(Philadelphia)
|
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.
Registered in England & Wales:
No.
3888792
Registered Office:
980 Great West
Road
Brentford,
Middlesex
TW8
9GS
[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.
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.
|
|
GlaxoSmithKline plc
|
|
|
(Registrant)
|
|
|
|
|
Date: April
19, 2022
|
|
|
|
|
|
|
By:/s/ VICTORIA
WHYTE
--------------------------
|
|
|
|
|
|
Victoria Whyte
|
|
|
Authorised
Signatory for and on
|
|
|
behalf
of GlaxoSmithKline plc
|