GSK's Eyes Benlysta Expansion With First US FDA Lupus Nephritis Approval

The new indication paves the way for Benlysta in a new patient population, as well as expansion in systemic lupus erythematosus, US specialty unit head Sheri Mullen said.

LONDON- JUNE, 2018: The GlaxoSmithKline headquarters building in Brentford, west London. A British global pharmaceuticals company. — GSK has a new indication for Benlysta • Source: Shutterstock

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...

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