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 August 2024
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 . . . . . . . .
GSK plc (the
'Company')
Transaction notification
Issued: 28 August 2024, London UK
GSK's Nucala (mepolizumab) approved in Japan for
treatment of adults with chronic rhinosinusitis with nasal
polyps
· Nucala is the first and only biologic in Japan with
a four-weekly dosing schedule for this
condition
· Chronic rhinosinusitis with nasal polyps (CRSwNP)
exerts significant physical and emotional burden on patients with
surgery often the only option
· This is the third indication
for Nucala in Japan for an IL-5 mediated
condition
GSK plc (LSE/NYSE: GSK) today announced that Japan's Ministry
of Health, Labour and Welfare (MHLW) has
approved Nucala (mepolizumab), a monoclonal antibody
that targets interleukin-5 (IL-5), for the treatment of
chronic rhinosinusitis with nasal polyps (CRSwNP) in adult
patients, limited to those who are inadequately controlled with
standard treatment.
Kaivan Khavandi, SVP, Global Head of Respiratory/Immunology
R&D, at GSK said: "The chronic and debilitating
impact that chronic rhinosinusitis with nasal polyps can have on
those affected is often underestimated. This additional indication
for Nucala in Japan could provide
patients with an alternative treatment option to surgery or
systemic steroids."
CRSwNP is a chronic condition that affects 1% to 4% of
the general population, of whom 40% have uncontrolled
disease.1,2 People
with CRSwNP experience symptoms such as nasal obstruction,
loss of smell, facial pressure, sleep disturbance and nasal
discharge, which can significantly affect their emotional and
physical well-being.3 In
Japan, an estimated 2 million people suffer from chronic
rhinosinusitis, of which about 200,000 are subject to surgery due
to nasal polyps.4
CRSwNP is caused by chronic inflammation of the nasal lining that
can cause soft tissue growth, known as nasal polyps, that develop
in the sinuses and nasal cavity.3 Over
80% of patients with CRSwNP have type 2 inflammation, which
is associated with more severe disease and nasal polyp
recurrence.5-8 IL-5
is a key cytokine driving this type 2 inflammation and is present
at high levels in nasal polyp tissue.3,5-8 Although
surgery can be effective at removing polyps, the underlying type 2
inflammation means they have a tendency to
regrow.7,8
The approval is based on results of the phase III MERIT trial,
which studied the efficacy and safety of mepolizumab over a
52-week period in a population of Japanese, Chinese and Russian
patients with inadequately controlled CRSwNP, supported by
data from the global phase III SYNAPSE study, which explored the
effect of mepolizumab vs. placebo in more than 400 patients with
CRSwNP.3,9
Mepolizumab is approved in Japan as a treatment for bronchial
asthma in children aged 6 years or older and in adults with
refractory asthma whose symptoms are inadequately controlled with
standard treatment, and also for the treatment of adult patients
with eosinophilic granulomatosis with polyangiitis (EGPA)
inadequately responding to the standard treatment.
About the MERIT
trial9
The phase III MERIT trial the co-primary endpoints were change from
baseline in nasal obstruction visual analogue scale (VAS) score
during weeks 49 to 52 compared with placebo and change in
endoscopic nasal polyp score at week 52 compared with
placebo.1 Treatment
with mepolizumab significantly improved nasal obstruction VAS score
(mean treatment difference: -1.43 [95% CI: -2.37, -0.50]; p=0.003)
and was associated with a numerical reduction in nasal polyp score
at Week 52 (-0.43 [-0.89, 0.03]; p=0.067). Improvements in patient
quality of life, as measured by the 22-item Sino-Nasal Outcome
Test (SNOT-22) were demonstrated with mepolizumab versus
placebo. Safety and tolerability data were consistent with the
known profile of mepolizumab.3,5 A
similar proportion of patients experienced on-treatment adverse
events in the mepolizumab (68/84 [81%]) and placebo (65/85 [76%])
groups. In total, seven patients had treatment-related AEs (five in
the placebo group and two in the mepolizumab group); none of these
were SAEs.
About Nucala (mepolizumab)
First approved in 2015 for severe asthma with an eosinophilic
phenotype in the US, mepolizumab is a monoclonal antibody that
targets and binds to interleukin-5 (IL-5), a key messenger protein
(cytokine) in type 2 inflammation.10,11 IL-5
is central to the development, maturation and activation of
eosinophils, a type of white blood cell implicated in the
pathogenesis of asthma and CRSwNP.3 Evidence
indicates that IL-5 has an impact on other cell types beyond
eosinophils that contribute to inflammation in airways
disease.12-16 Mepolizumab
binds directly to and inhibits IL-5 molecules.10,11 Mepolizumab
has been developed for the treatment of a range of IL-5 mediated
diseases associated with type 2 inflammation.10,11
GSK in respiratory
GSK continues to build on decades of pioneering work to deliver
more ambitious treatment goals, develop the next generation
standard of care, and redefine the future of respiratory medicine
for hundreds of millions of people with respiratory diseases. With
an industry-leading respiratory portfolio and pipeline of vaccines,
targeted biologics and inhaled medicines, we are focused on
improving outcomes and the lives of people living with all
types of asthma and COPD along with less understood refractory
chronic cough or rarer conditions like systemic sclerosis with
interstitial lung disease. GSK is harnessing the latest science and
technology with the aim to modify underlying disease dysfunction
and prevent disease progression.
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.
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GSK enquiries
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Media:
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Tim Foley
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(London)
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Sarah Clements
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(London)
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Kathleen Quinn
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+1 202 603 5003
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(Washington DC)
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Lyndsay Meyer
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+1 202 302 4595
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(Washington DC)
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Investor Relations:
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Nick Stone
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+44 (0) 7717 618834
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(London)
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James Dodwell
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+44 (0) 20 8047 2406
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(London)
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Mick Readey
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+44 (0) 7990 339653
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Josh Williams
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+44 (0) 7385 415719
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Camilla Campbell
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+44 (0) 7803 050238
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(London)
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Steph Mountifield
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+44 (0) 7796 707505
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(London)
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Jeff McLaughlin
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+1 215 751 7002
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(Philadelphia)
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Frannie DeFranco
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+1 215 751 4855
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(Philadelphia)
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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 under Item 3.D
"Risk factors" in GSK's Annual Report on Form 20-F for 2023, and
GSK's Q2 Results for 2024.
Registered in England & Wales:
No. 3888792
Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
References
1. Chen S, et
al. Systematic literature review of the epidemiology and clinical
burden of chronic rhinosinusitis with nasal
polyposis. Curr Med Res
Opin.
2020;36(11):1897-1911.
2. van der
Veen J, et al. Real-life study showing uncontrolled rhinosinusitis
after sinus surgery in a tertiary referral
centre. Allergy. 2017;72(2):282-290.
3. Han JK, et
al. Mepolizumab for chronic rhinosinusitis with nasal polyps
(SYNAPSE): a randomised, double-blind, placebo-controlled, phase 3
trial. The Lancet Respiratory
Medicine. 2021;9(10):1141-1153.
4. JESREC
Study About refractory
eosinophilic sinusitis available at https://jesrec.jp/general/disease.html.
Last accessed September 2023.
5. Kato A, et
al. Endotypes of chronic rhinosinusitis: Relationships to disease
phenotypes, pathogenesis, clinical findings, and treatment
approaches. Allergy. 2022;77(3):812-826.
6. Bachert C,
et al. EUFOREA expert board meeting on uncontrolled severe chronic
rhinosinusitis with nasal polyps (CRSwNP) and biologics:
Definitions and management. J Allergy Clin
Immunol.
2021;147(1):29-36.
7. De Corso E,
et al. How to manage recurrences after surgery in CRSwNP patients
in the biologic era: a narrative review. Acta Otorhinolaryngol
Ital. 2023;43(Suppl.
1):S3-S13.
8. Chen S, et
al. Systematic literature review of the epidemiology and clinical
burden of chronic rhinosinusitis with nasal
polyposis. Curr Med Res
Opin. 2020;36(11):1897-1911.
9. Fujieda S, et al. Mepolizumab in CRSwNP/ECRS and NP: The Phase
III randomised MERIT trial in Japan, China and
Russia. Rhinology (2024)
10. U.S. Food and Drug
Administration. Nucala Full Prescribing Information. Available
at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761122s000lbl.pdf.
Last accessed December 2023.
11. 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
12. Buchheit KM, et al.
Mepolizumab targets multiple immune cells in aspirin-exacerbated
respiratory disease. J Allergy Clin
Immunol.
2021;148(2):574-584.
13. Barretto KT, et al.
Human airway epithelial cells express a functional IL-5
receptor. Allergy. 2020;75(8):2127-2130.
14. Bajbouj K, et al. IL-5
receptor expression in lung fibroblasts: Potential role in airway
remodelling in asthma. Allergy. 2023;78(3):882-885.
15. Siddiqui S, et al.
Eosinophils and tissue remodelling: Relevance to airway
disease. J Allergy Clin
Immunol.
2023;152(4):841-857.
16. Bergantini L, et al.
Regulatory T cell monitoring in severe eosinophilic asthma patients
treated with mepolizumab. Scand J
Immunol.
2021;94(1):e13031.
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.
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GSK plc
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(Registrant)
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Date: August
28, 2024
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By:/s/ VICTORIA
WHYTE
--------------------------
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GSK plc
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