FDA Approves Benlysta for Children 5 Years and Up

Benlysta is now the only biologic approved for adults and children who have lupus or lupus nephritis, an inflammation of the kidneys.

The FDA has approved GSK’s Benlysta (belimumab) to treat children aged 5 to 17 with active lupus nephritis (LN), a serious inflammation of the kidneys caused by lupus that can lead to end-stage kidney disease. It was previously approved for adults with systemic lupus erythematosus.

This is the first FDA-approved treatment for pediatric LN, which remains a driving factor in increased complications, hospitalizations and mortality rates in children. 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,” Stevan W. Gibson, president and CEO, Lupus Foundation of America, said in a press release. “This approval marks a significant step forward in providing treatment options to these children at risk of incurring kidney damage early on in life.”

Benlysta is a human monoclonal antibody that binds to soluble BLyS and inhibits the survival of B cells. First approved in 2011, it is the first and only approved biologic for both systemic lupus erythematosus and lupus nephritis in more than 50 years.

Systemic lupus erythematosus (SLE), the most common form of lupus, is a chronic, incurable, autoimmune disease associated with a range of symptoms that can fluctuate over time including painful or swollen joints, extreme fatigue, unexplained fever, skin rashes and organ damage.