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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]
Since lupus nephritis is a serious, disabling, and possibly life-threatening illness, it is not surprising to see mortality in lupus nephritis clinical trials. Voclosporin safety information originates from a total of 267 patients who received 23.7 mg BID and an additional 88 patients who received 39.5 mg BID.
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 ...
FDA grants EUA to Eli Lilly's (LLY) new COVID antibody-drug, bebtelovimab. AstraZeneca's (AZN) Saphnelo and Pfizer's (PFE) Ngenla (somatrogon) and Apexxnar vaccine get approval in Europe
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]