GSK Announces FDA Approval of Benlysta as First Therapy for Lupus Nephritis in Adults

GlaxoSmithKline (GSK) announced today that the U.S. FDA has approved an expanded indication for Benlysta (belimumab) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy. Lupus nephritis is a severe kidney inflammation caused by systemic lupus erythematosus (SLE), which can lead to end-stage renal disease requiring dialysis or kidney transplantation. The press release noted that this is the first therapy approved by the FDA specifically for lupus nephritis.

Systemic lupus erythematosus (SLE) is the most common type of lupus, a chronic and incurable autoimmune disease. Patient symptoms include joint pain or swelling, extreme fatigue, unexplained fever, rash, and organ damage. In lupus nephritis, the immune system attacks the kidneys, causing inflammation in the small blood vessels that filter waste from the kidneys, leading to symptoms such as proteinuria, elevated serum creatinine, and urinary sediment abnormalities. Despite improvements in diagnosis and treatment over the past few decades, lupus nephritis remains an indicator of poor prognosis.

Benlysta is a monoclonal antibody that binds to soluble B-lymphocyte stimulator (BLyS). Benlysta does not bind directly to B cells; by binding to BLyS, it inhibits the survival of B cells (including autoreactive B cells) and reduces the differentiation of B cells into immunoglobulin-producing plasma cells. First approved in 2011, Benlysta is the first and only biologic agent approved in over 50 years for the treatment of systemic lupus erythematosus and lupus nephritis.

The FDA approval was based on the positive results from BLISS-LN, a randomized, double-blind, placebo-controlled Phase 3 clinical trial. This trial included 448 adult patients. The results demonstrated that, in adult patients with active lupus nephritis, the proportion of patients achieving the Primary Efficacy Renal Response (PERR) after two years of treatment was significantly higher in the Benlysta plus standard-of-care group (43%) compared to the placebo plus standard-of-care group (32%) (p=0.0311). Compared with placebo, all four key secondary endpoints achieved statistical significance, including complete renal response and time to occurrence of kidney-related events or death.

References:

[1] FDA approves GSK's BENLYSTA as the first medicine for adult patients with active lupus nephritis in the US. Retrieved December 17, 2020, from https://www.prnewswire.com/news-releases/fda-approves-gsks-benlysta-as-the-first-medicine-for-adult-patients-with-active-lupus-nephritis-in-the-us-301195182.html

[2] LRA Pleased to Share GSK's Benlysta® (belimumab) is First Lupus Nephritis Treatment Approved by FDA. Retrieved December 17, 2020, from https://www.prnewswire.com/news-releases/lra-pleased-to-share-gsks-benlysta-belimumab-is-first-lupus-nephritis-treatment-approved-by-fda-301195383.html

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