The US Food and Drug Administration (FDA) has approved GSK’s 200 mg/ml autoinjector of Benlysta for individuals aged five years and above with active lupus nephritis (LN), who are currently receiving standard treatments.
This approval provides patients with a subcutaneous option that can be self-administered at home.
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In 2024, the autoinjector was approved for active systemic lupus erythematosus (SLE) in paediatric patients.
With this approval, GSK broadens the therapeutic possibilities for belimumab treatment by offering a subcutaneous method specifically designed to aid paediatric LN patients and their caregivers.
GSK senior vice-president and US Specialty head Court Horncastle stated: “For children and parents of children with lupus nephritis, this approval represents a choice in their care.
“Providing this at-home treatment option with the efficacy and safety of Benlysta is a testament to our ongoing commitment to the lupus community. GSK is driven by the belief that our therapeutic solutions should always prioritise improving patients’ well-being and easing their treatment journey, including for younger patients.”
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By GlobalDataLN is a severe complication of lupus, characterised by autoimmune attacks on the kidneys, which may lead to inflammation and potential organ damage.
Between 30% and 50% of children diagnosed with this condition develop LN within one to two years of their initial diagnosis.
Belimumab functions as an inhibitor that selectively binds to soluble B-lymphocyte stimulator (BLyS), inhibiting B cell survival, including the autoreactive B cells, thereby reducing their differentiation into plasma cells responsible for immunoglobulin (IG) production.
The therapy received its initial FDA approval as a treatment option for active SLE. It stands out as the sole biologic approved for both SLE and LN across more than 50 years, extending its benefits to paediatric patients.
