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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]
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.
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.
The drug is also being tested in two other blood disorders, atypical hemolytic uremic syndrome and sickle cell disease, and a kidney disease called lupus nephritis. (Reporting by Puyaan Singh in ...
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This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage. See the list of FDA-approved therapeutic monoclonal antibodies in the monoclonal antibody therapy page.
Food and Drug Administration review times usually offer little in the way of a hint at the likelihood of approval. Sometimes drugs are given a priority review because they treat an unmet need and ...