GSK Announces FDA Approval of Benlysta (Belimumab) as First Treatment for Pediatric Active Lupus Nephritis

Recently, GlaxoSmithKline (GSK) announced that the U.S. Food and Drug Administration (FDA) has approved Benlysta (generic name: belimumab for injection) for the treatment of active lupus nephritis (LN) in patients aged 5-17 who are receiving standard therapy. Lupus nephritis is a severe kidney inflammation caused by systemic lupus erythematosus, which can lead to end-stage kidney disease (ESKD), necessitating dialysis or kidney transplantation. This approval expands Benlysta's current indications in the United States to include intravenous treatment for pediatric systemic lupus erythematosus and active lupus nephritis.

Belimumab is the first treatment approved by the US FDA for pediatric active lupus nephritis. Lupus nephritis is a significant factor in the increased incidence of complications, hospitalizations, and mortality in children. Prior to this approval of belimumab, treatment options for pediatric lupus nephritis were primarily limited to non-selective immunosuppressants and corticosteroids.

Stevan W. Gibson, President and CEO of the Lupus Foundation of America, stated: "Active lupus nephritis is a potentially serious complication faced by pediatric patients with systemic lupus erythematosus, mostly occurring within two years after the diagnosis of systemic lupus erythematosus. For these young patients who are at risk of kidney damage early in life, the approval of this new indication provides them with a new treatment option, which is highly significant."

Herson Quinones, Vice President of Medical Affairs for GSK US Specialty Medicines and Pipeline, stated: "The long-term goal in treating lupus nephritis in both adults and children is to preserve kidney function while minimizing drug-related toxicity and side effects. The approval of this new indication for Benlysta underscores GSK's commitment to providing treatment options for children with lupus nephritis, and further demonstrates GSK’s dedication to science, grounded in over a decade of clinical experience, continuing to lead the way in the field of lupus treatment."

GSK is continuously exploring ways to improve the quality of life for lupus patients and researching how to protect and prevent organ and kidney damage in adult and pediatric lupus and active lupus nephritis patients.

Editor: Eight Corners