TIDMGSK
RNS Number : 4982O
GSK PLC
01 February 2023
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
Media: Tim Foley +44 (0) 20 8047 (London)
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Investor Relations: Nick Stone +44 (0) 7717 618834 (London)
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Mick Readey +44 (0) 7990 339653 (London)
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Steph Mountifield +44 (0) 7736063933 (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, GSK's Q4 Results for 2022 and
any impacts of the COVID-19 pandemic.
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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.
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