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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.
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage.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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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
CAT was also behind belimumab, the anti-BlyS antibody drug marketed as Benlysta and the first new approved drug for systemic lupus in more than 50 years. [1] In 2018, the Nobel Prize organisation awarded one quarter of the Nobel Prize in Chemistry to a founding member of CAT, Sir Greg Winter FRS "for the phage display of peptides and antibodies ...
The approval is based on a late-stage study in which PiaSky showed a 79.3% control in the destruction of red blood cells versus 79% for the standard-of-care eculizumab from week 5 to week 25.
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]