Lupus Foundation of America Sees Big Win with FDA Approval of Benlysta for Lupus Nephritis
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WASHINGTON, Dec. 17, 2020 /PRNewswire/ The U.S. Food and Drug Administration (FDA) has approved Benlysta to treat lupus nephritis (lupus-related kidney disease) in adults. The approval is for both the intravenous and subcutaneous formulations. The decision makes Benlysta the first lupus therapy authorized to treat this potentially life-threatening complication of the disease. Up to 60 percent of people with lupus will develop lupus nephritis.
Benlysta is a human monoclonal antibody sold by GSK. The FDA first approved Benlysta for lupus in 2011. However, at that time, Benlysta had not been studied for use in individuals with severe lupus nephritis.