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Belimumab, sold under the brand name Benlysta, is a human monoclonal antibody that inhibits B-cell activating factor (BAFF), [6] also known as B-lymphocyte stimulator (BLyS). [7] It is approved in the United States [8] and Canada, [9] and the European Union [5] to treat systemic lupus erythematosus and lupus nephritis. [10]
Hydroxychloroquine was approved by the FDA for lupus in 1955. [120] Some drugs approved for other diseases are used for SLE 'off-label'. In November 2010, an FDA advisory panel recommended approving belimumab (Benlysta) as a treatment for the pain and flare-ups common in lupus. The drug was approved by the FDA in March 2011. [121] [122]
AstraZeneca's Saphnelo, approved in 2021, made $280 million in 2023 sales, while GSK's Benlysta, which first gained approval in 2011, brought in 1.35 billion euros ($1.50 billion) last year.
Voclosporin, sold under the brand name Lupkynis, is a calcineurin inhibitor used as an immunosuppressant medication for the treatment of lupus nephritis. [2] [4] It is an analog of ciclosporin that has enhanced action against calcineurin and greater metabolic stability.
Pharmaceutical maker GlaxoSmithKline will begin a phase 3 clinical trial to judge lupus medication Benlysta's effectiveness in treating patients with ANCA-positive vasculitis. The trial, which ...
Not anymore -- sales of newly approved drugs are no longer a foregone conclusion. Witness Incyte (NAS: INCY) , which spiked In Biotech, Approval's Important, but It's the Launch That Counts
Childhood-onset systemic lupus erythematosus (i.e., cSLE), also termed juvenile-onset systemic lupus erythematosus, juvenile systemic lupus erythematosus, and pediatric systemic lupus erythematosus, is a form of the chronic inflammatory and autoimmune disease, systemic lupus erythematosus (i.e., SLE), that develops in individuals up to 18 years old. [1]
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