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GSK Announces US FDA Approval of Benlysta (Belimumab) for Pediatric Patients With Active Lupus Nephritis
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GSK plc: GSK Announces US FDA Approval of Benlysta (Belimumab) for Pediatric Patients With Active Lupus Nephritis
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FDA approves GSK s BENLYSTA as the first medicine for adult patients with active lupus nephritis in the US
Approval builds on nearly 10 years of experience in lupus
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LONDON, Dec. 17, 2020 /PRNewswire/ GlaxoSmithKline plc (LSE/NYSE: GSK) announced the US Food and Drug Administration (FDA) has approved BENLYSTA (belimumab) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy. Lupus nephritis is a serious inflammation of the kidneys caused by systemic lupus erythematosus (SLE), the most common form of lupus, which can lead to end-stage kidney disease, requiring dialysis or a kidney transplant. The approval extends the current indication in the US to include both SLE and LN for both the intravenous and subcutaneous formulations.