GlaxoSmithKline plc's Benlysta (belimumab) is the first drug approved by the US Food and Drug Administration for the treatment of adults with active lupus nephritis, the acute kidney disease caused by systemic lupus erythematosus (SLE). Benlysta has been approved in the US for SLE since 2011, but the new approval, for both the intravenous and subcutaneous versions, is a first for lupus nephritis.
GSK announced the approval on 17 December, with the company beating another close rival to the punch. Aurinia Pharmaceuticals Inc. also has a drug under review at the FDA for lupus nephritis; voclosporin has a 22 January action date. (Also see "First Drugs For Lupus Nephritis Are Headed For US FDA Review" - Scrip, 4 June, 2020