Benlysta approved for adult patients with active lupus nephritis in Europe
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The indication of Benlysta (belimumab) was extended after it significantly improved renal outcomes in those with active lupus nephritis.
The European Commission (EC) has approved the expanded use of intravenous (IV) and subcutaneous Benlysta (belimumab) in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis (LN), in addition to systemic lupus erythematosus (SLE).
Dr Hal Barron, Chief Scientific Officer and President R&D, GlaxoSmithKline (developer of Benlysta) stated: “Active lupus nephritis, which causes inflammation in the kidneys, is one of the most serious consequences of systemic lupus erythematosus and occurs in more than one million patients worldwide. Benlysta is the first biologic approved to treat lupus and lupus nephritis, representing a significant new treatment option for patients and physicians across Europe dealing with
EC clears GSK s Benlysta for lupus nephritis
6th May 2021
The European Commission approved expanded use of GlaxoSmithKline’s intravenous and subcutaneous Benlysta (belimumab) in combination with background immunosuppressive therapies for adults with active lupus nephritis (LN).
The drug is already on the market to treat systemic lupus erythematosus (SLE); this latest approval now provides physicians and patients in Europe with the first and only biologic treatment specifically designed to work in lupus and LN.
“Active lupus nephritis, which causes inflammation in the kidneys, is one of the most serious consequences of systemic lupus erythematosus and occurs in more than 1 million patients worldwide,” noted Dr Hal Barron, GSK s chief scientific officer and president R&D.
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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.