FDA approves belimumab for lupus nephritis for pediatric patients

The FDA has approved belimumab for the treatment of active lupus nephritis for children who are also receiving standard therapy. The drug is being manufactured and marketed by GlaxoSmithKline.

This is the first FDA-approved treatment for pediatric lupus nephritis, which remains a driving factor in increased complications, hospitalizations and mortality rates in children[ii]. Prior to this, treatment options for children were mainly limited to use of non-selective immunosuppressants and corticosteroids.

"Active lupus nephritis is a potential serious complication in children with lupus, with most cases occurring within the first two years after their initial lupus diagnosis," said Stevan W. Gibson, President and CEO, Lupus Foundation of America. "This approval marks a significant step forward in providing treatment options to these children at risk of incurring kidney damage early on in life."

"The long-term goal of lupus nephritis management in adults and children is to preserve renal function while minimizing treatment-related toxicities and associated morbidity," said Herson Quinones, VP, Specialty and Pipeline US Medical Affairs, GSK.

"This Benlysta approval highlights GSK's commitment to bring treatment options to children living with lupus nephritis. This is another example of how GSK continues to get ahead of this burdensome disease by focusing on science and being grounded in over a decade of clinical experience."

Through ongoing research, GSK is committed to improving the lives of those living with lupus and researching ways to prevent organ and kidney damage in adults and children living with lupus and active LN.

References:

1. National Institute of Diabetes and Digestive and Kidney Diseases. Lupus and Kidney Disease (Lupus Nephritis). Available at www.niddk.nih.gov/health-information/kidney-disease/lupus-nephritis

2. Ardoin, S.P., Daly, R., Merzoug, L. et al. Research priorities in childhood-onset lupus: results of a multidisciplinary prioritization exercise. Pediatr Rheumatol 2019; 17, 32.

3. National Kidney Foundation, Lupus and Kidney Disease (Lupus Nephritis). Available at www.kidney.org/atoz/content/lupus

4. Gordon C, Hayne D, Pusey C, et al. European Consensus Statement on the Terminology used in the Management of Lupus Glomerulonephritis. Lupus 2009;18:257-26.

5. Waldman M and Appel GB. Update of the Treatment of Lupus Nephritis. Kidney International 2006;70:1403-1412.