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DECEMBER 18, 2020

FDA Grants New Indication for Benlysta to Lupus Nephritis

By SPC News Staff

The FDA granted a new indication for intravenous and subcutaneous belimumab (Benlysta, GlaxoSmithKline) for adults with active lupus nephritis (LN) who are receiving standard therapy. 

Lupus nephritis is a serious inflammation of the kidneys caused by systemic lupus erythematosus (SLE)—the most common form of lupus—that can lead to end-stage kidney disease, requiring dialysis or a kidney transplant. 

The FDA approval is based on the positive results of the