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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]
Belimumab is a monoclonal antibody that inhibits B-cell activating factor and thereby inflammation. It was approved in 2019 by the US Food and Drug Administration to treat the musculoskeletal, cutaneous, and cardiac manifestations of children with cSLE who are over 5 years old. It is given intravenously to cSLE patients with active disease but ...
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.
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage.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.
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