FDA approves GSK's Benlysta as first med for active lupus nephritis in adults

The US Food and Drug Administration has approved Benlysta (belimumab) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy, UK pharma major GlaxoSmithKline (LSE: GSK) has announced.

Lupus nephritis is a serious inflammation of the kidneys caused by systemic lupus erythematosus (SLE), the most common form of lupus, which can lead to end-stage kidney disease, requiring dialysis or a kidney transplant. The approval extends the current indication in the US to include both SLE and LN for both the intravenous and subcutaneous formulations.

First approved in 2011, it is the first and only approved biologic for both SLE and LN in more than 50 years. Benlysta generated 2919 revenues of $783 million and first-half 2020 sales of $419 million.