REG - GSK PLC - Benlysta granted Orphan Drug Designation by US FDA

GSKAnnouncement

01/02/2023 07:15

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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
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Benlysta/pdf/BENLYSTA-PI-MG-IFU.PDF)
BENLYSTA
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Benlysta/pdf/BENLYSTA-PI-MG-IFU.PDF)
.

 

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
(https://www.gsk.com/en-gb/company/) .

 

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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.

 

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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
(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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