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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]
Lecanemab was jointly developed by Eisai and Biogen. It was granted accelerated approval for medical use in the United States in January 2023, [7] and fully approved by the FDA in July 2023. [4] [8] Lecanemab was approved for medical use in South Korea in May 2024, [9] and in Mexico in December 2024. [10]
Lecanemab was jointly developed by Eisai and Biogen. It was granted accelerated approval for medical use in the United States in January 2023, [27] and fully approved by the FDA in July 2023. [24] [28] Lecanemab was approved for medical use in South Korea in May 2024, [29] and in Mexico in December 2024. [30]
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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]
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[33] [34] The phase 3 clinical trials also reported infusion related reactions, amyloid-related imaging abnormalities and headaches as the most common side effects of Lecanemab. In July 2023 the FDA gave Lecanemab full approval for the treatment of Alzheimer's Disease [35] and it was given the commercial name Leqembi.