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 March 2023
Commission
File Number 001-15170
GSK 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: 14 March 2023, London UK
China National Medical Products
Administration accepts regulatory submission
for Nucala (mepolizumab) in severe eosinophilic
asthma
GSK plc (LSE/NYSE: GSK) today announced
that the China National Medical Products
Administration has accepted
for review a new drug application for Nucala (mepolizumab)
as an
add-on maintenance
treatment for severe eosinophilic asthma (SEA). If
approved, Nucala would
be the first targeted anti-Interleukin-5 (IL-5) treatment in
China for
adult and adolescent patients with this
condition.
The application is based on positive data from a phase III trial among Chinese
patients1 and
the global SEA development programme, which included three key
clinical trials - DREAM2,
MENSA3 and
SIRIUS4 -
that established the efficacy and safety profile of mepolizumab for
severe eosinophilic asthma patients. The 52-week phase III
trial in Chinese patients studied the effect of mepolizumab as
adjunctive therapy in patients with SEA with a primary endpoint of
reduction, relative to placebo, in the annual rate of clinically
significant exacerbations.1 The
efficacy and safety of mepolizumab in the Chinese population were
shown to be consistent with that in a non-Chinese population with
SEA.2-5
Asthma affects an estimated 46 million adults in China,
with 6%
experiencing severe asthma.6-8
Patients with SEA have an increased risk of exacerbations requiring
hospitalisation or an increased likelihood of a potentially fatal
asthma attack.9,10 Guidelines
for bronchial asthma prevention and management (2020 edition) from
the Asthma group of the Chinese Thoracic Society reference the
current unmet need among Chinese patients
with SEA.11
Nucala is
currently approved
in China for use in adults with eosinophilic granulomatosis with
polyangiitis (EGPA) and was included on the National Reimbursement
Drug List in January 2023. However, Nucala is not currently
approved in China for the treatment of SEA.
About Nucala (mepolizumab)
First approved in 2015 for SEA in the US, Nucala is the first-in-class monoclonal antibody to
target IL-5. It is believed to work by preventing IL-5 from binding
to its receptor on the surface of eosinophils, reducing blood
eosinophils and maintaining them within normal
levels.12
Nucala has
been studied in over 4,000 patients in 41 clinical trials across
several eosinophilic indications and was the first treatment
approved in the US across four eosinophil-driven diseases: SEA,
EGPA, hypereosinophilic syndrome and chronic rhinosinusitis with
nasal polyps. Nucala has
been approved in the US, the European Union and over 25 other
markets as an add-on maintenance treatment for patients with
SEA.
About severe eosinophilic asthma
Severe asthma is defined as asthma which requires treatment with
high-dose inhaled corticosteroids plus a second controller (and/or
systemic corticosteroids) to prevent it from becoming
'uncontrolled' or which remains 'uncontrolled' despite this
therapy.2-5 Severe
asthma patients can also be categorised by long-term oral
corticosteroid use. In a sub-set of severe asthma patients, the
over-production of eosinophils (a type of white blood cell) is
known to cause inflammation in the lungs; this is known as
SEA.2-5 IL-5
is the leading promoter of eosinophil growth, activation and
survival and provides an essential signal for the movement of
eosinophils from the bone marrow into the
lung. The majority (up to
80%) of severe asthma patients are eosinophilic, according to a
real-world observational study13.
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
GSK enquiries
|
|
|
|
Media:
|
Tim
Foley
|
+44 (0)
20 8047 5502
|
(London)
|
|
Dan
Smith
|
+44 (0)
20 8047 5502
|
(London)
|
|
Kathleen
Quinn
|
+1 202
603 5003
|
(Washington
DC)
|
|
Lyndsay
Meyer
|
+1 202
302 4595
|
(Washington
DC)
|
|
|
|
|
Investor
Relations:
|
Nick
Stone
|
+44 (0)
7717 618834
|
(London)
|
|
James
Dodwell
|
+44 (0)
20 8047 2406
|
(London)
|
|
Mick
Readey
|
+44 (0)
7990 339653
|
(London)
|
|
Josh
Williams
|
+44 (0)
7385 415719
|
(London)
|
|
Camilla
Campbell
|
+44 (0)
7803 050238
|
(London)
|
|
Steph
Mountifield
|
+44 (0)
7796 707505
|
(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 under Item 3.D
'Risk factors" in the company's Annual Report on Form 20-F for
2022, GSK's Q4 Results for 2022 and any impacts of the COVID-19
pandemic.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
References
1. A Safety and
Efficacy Study of Mepolizumab in Subjects With Severe Asthma
(NCT03562195) available at A
Safety and Efficacy Study of Mepolizumab in Subjects With Severe
Asthma - Full Text View - ClinicalTrials.gov last
accessed February 2023
2. Pavord,
I. D. et
al. Mepolizumab for
severe eosinophilic asthma (DREAM): a multicentre, double-blind,
placebo-controlled trial. The
Lancet. 2012. 380, ISSUE (9842) 651-659
3. Ortega,
H.G et al Mepolizumab Treatment
in Patients with Severe Eosinophilic
Asthma. N
Engl J Med 2014;
371:1198-1207
4. Bell,
E.H. et
al. Oral
Glucocorticoid-Sparing Effect of Mepolizumab in Eosinophilic
Asthma. N Engl J
Med 2014;
371:1189-1197. DOI:
10.1056/NEJMoa1403291
5.
Chupp GL, et
al. Efficacy of mepolizumab add-on therapy on
health-related quality of life and markers of asthma control in
severe eosinophilic asthma
(MUSCA): a
randomised, double-blind, placebo-controlled, parallel group,
multicentre, phase 3b trial. Lancet Respir
Med. 2017;5(5):390-400. Su N, et. al. Chin J Intern
Med.2016, 55(12):917-921.
6. Huang
K, Yang T, Xu J, et
al. Prevalence, risk factors, and management of asthma in
China: a national cross-sectional study. Lancet. 2019;
394:407-418.
7. Ding
B, Small M, Wang W, et al. The disease burden of mild asthmatics in
China. European Respiratory
Journal. 2016; 48 (suppl 60): PA4208
8. National
Heart, Lung, and Blood Institute. Guidelines for the Diagnosis and
Management of Asthma (EPR-3). [Online]. Available at:
https://www.nhlbi.nih.gov/health-topics/guidelines-for-diagnosis-management-of-asthma.
[Accessed February 2023]
9.
Ambrosino, N and Paggiaro, P. The management of asthma and chronic
obstructive pulmonary disease: current status and future
perspectives Expert Rev. Respir. Med. 6(1), 117-127
(2012)2012;
10.
Antonicelli, L et
al. Asthma severity and medical resource utilisation.
Eur Respir J 2004; 23: 723-729
11. China Asthma Guideline
2020 支气管哮喘防治指南(2020年版). 中华结核和呼吸杂志, 43(12),
26
12. European summary of
product characteristics available at https://www.ema.europa.eu/en/documents/product-information/nucala-epar-product-information_en.pdf last
accessed February 2023
13.
Azim A, et al. Clinical evaluation of type 2 disease status in a
real-world population of difficult to manage asthma using historic
electronic healthcare records of blood eosinophil counts. Clin Exp
Allergy. 2021 Jun;51(6):811-820.
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.
|
GSK plc
|
|
(Registrant)
|
|
|
Date: March
14, 2023
|
|
|
|
|
By:/s/ VICTORIA
WHYTE
--------------------------
|
|
|
|
Victoria Whyte
|
|
Authorised
Signatory for and on
|
|
behalf
of GSK plc
|
GSK (NYSE:GSK)
Historical Stock Chart
From Apr 2024 to May 2024
GSK (NYSE:GSK)
Historical Stock Chart
From May 2023 to May 2024