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 February 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: 1 February 2023, London UK
Benlysta granted
Orphan Drug Designation by US FDA for the potential treatment of
systemic sclerosis
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug
Administration (FDA) has granted Orphan Drug Designation (ODD)
to Benlysta (belimumab), a B-cell inhibiting monoclonal
antibody, for the potential treatment of systemic sclerosis. GSK
plans to initiate a phase II/III trial of belimumab for systemic
sclerosis associated interstitial lung disease (SSc-ILD) in the
first half of 2023.
Systemic sclerosis (SSc) is a rare autoimmune disease that causes
atypical growth of connective tissues and can affect the
musculoskeletal system, heart, lungs, kidneys, skin, and other
organs. Interstitial lung disease (ILD) is the leading cause of
death in SSc, affecting as many as half of people living with the
disease.1,2
With limited treatment options available for SSc-ILD, this Orphan
Drug Designation reflects the need for further research and the
potential for belimumab to address a critical need for people
living with this debilitating condition. GSK continues to follow
the science to explore how belimumab may be able to address an
unmet need in B-cell-driven autoimmune diseases.
The US FDA's ODD
is a special status granted to support the development and
evaluation of potential new medicines intended for the treatment,
diagnosis or prevention of rare diseases or disorders that affect
fewer than 200,000 people in the US.
About Benlysta (belimumab)
Benlysta (belimumab)
is a B-lymphocyte stimulator (BLyS) specific inhibitor that binds
to soluble BLyS, which is found to be increased in patients with
systemic autoimmune diseases like systemic lupus erythematosus
(SLE) and lupus nephritis (LN).3 A
fully human monoclonal antibody, Benlysta inhibits the prolonged survival of B cells
induced by increased BLyS, including autoreactive B cells, and
reduces the differentiation of B cells into
immunoglobulin-producing plasma cells. The US FDA first
approved Benlysta for the treatment of active SLE; it is
the first and only approved biologic for both SLE and LN in more
than 50 years, including for the paediatric
population.
Please see the US
Prescribing Information for BENLYSTA.
About SSc-ILD
Research indicates that elevated BLyS and autoreactive B cells play
a central role in the pathogenesis of SSc, a rare autoimmune
disease affecting 2.3-10 people per million.4,5 SSc
is characterised by microvascular damage, dysregulation of immunity
and progressive fibrosis in multiple organs.2,6 ILD
is a common and serious complication, marked by inflammation and
scar tissue build-up in the lungs. ILD is observed in as many as
half of SSc patients and is a significant contributor to patients'
disease burden and mortality.1 There
is a recognised need for additional effective, well-tolerated,
disease-modifying treatment options for SSc-ILD.2
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
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Media:
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Tim Foley
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+44 (0) 20 8047 5502
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(London)
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Dan Smith
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+44 (0) 20 8047 5502
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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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(London)
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Josh Williams
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+44 (0) 7385 415719
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(London)
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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) 7736063933
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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 in the Company's
Annual Report on Form 20-F for 2021, 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] Vonk MC, Smith V, Sfikakis PP,
Cutolo M, Del Galdo F, Seibold JR. Pharmacological treatments for
SSc-ILD: Systematic review and critical appraisal of the evidence.
Autoimmun Rev. 2021 Dec;20(12):102978. doi:
10.1016/j.autrev.2021.102978. Epub 2021 Oct 28. PMID: 34718159.
Available at:
https://www.sciencedirect.com/science/article/pii/S1568997221002585?via%3Dihub.
2 Fischer A, Patel NM, Volkmann
ER. Interstitial Lung Disease in
Systemic Sclerosis: Focus on Early Detection and Intervention. Open
Access Rheumatol. 2019 Dec 9;11:283-307. doi:
10.2147/OARRR.S226695. PMID: 31849543; PMCID: PMC6910104. Available
at:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6910104/.
3 Parodis I, Zickert A, Sundelin B,
et alEvaluation of B lymphocyte stimulator and a proliferation
inducing ligand as candidate biomarkers in lupus nephritis based on
clinical and histopathological outcome following induction therapy
Lupus Science & Medicine 2015;2:e000061. doi:
10.1136/lupus-2014-000061.
4 Thoreau, B., Chaigne, B., &
Mouthon, L. (2022). Role of B-Cell in the Pathogenesis of Systemic
Sclerosis. Frontiers in immunology, 13, 933468.
https://doi.org/10.3389/fimmu.2022.933468.
5 Ghosh, S. K., Bandyopadhyay, D.,
Saha, I., & Barua, J. K. (2012). Mucocutaneous and demographic
features of systemic sclerosis: a profile of 46 patients from
eastern India. Indian journal of dermatology, 57(3),
201-205. https://doi.org/10.4103/0019-5154.96193.
6 Truchetet ME, Brembilla NC,
Chizzolini C. Current Concepts on the Pathogenesis of Systemic
Sclerosis. Clin Rev Allergy Immunol. 2021 Sep 6. doi:
10.1007/s12016-021-08889-8. Epub ahead of print. PMID: 34487318.
Available at:
https://link.springer.com/article/10.1007/s12016-021-08889-8.
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: February
01, 2023
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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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