FDA Approves Belimumab for Pediatric Patients with Lupus Nephritis

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The US Food and Drug Administration (FDA) has approved belimumab (Benlysta) for the treatment of active lupus nephritis in children aged 5 to 17 who are currently receiving standard therapy. The approval extends the current indication for the intravenous formulation in this patient population.

“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 of Lupus Foundation of America, stated. “This approval marks a significant step forward in providing treatment options to these children at risk of incurring kidney damage early on in life.”

Belimumab is a BLyS-specific inhibitor that binds to soluble BLyS. The drug does not bind to B cells directly and instead inhibits the survival of B cells and reduces the differentiation of B cells into immunoglobulin-producing plasma cells.

The drug is the first and only FDA-approved biologic treatment option for adults and children with lupus or lupus nephritis in more than 50 years. Lupus nephritis is a serious inflammation of the kidneys caused by systemic lupus erythematosus (SLE) that can lead to end-stage kidney disease, kidney dialysis, or transplant. It also increases the likelihood of complications, hospitalizations, and mortality rates in pediatric patients. Previously, treatments were limited to non-selective immunosuppressants and corticosteroids.

Adverse reactions reported in pediatric patients with SLE were consistent with adult SLE trials. The most common reactions were nausea, diarrhea, insomnia, bronchitis, pyrexia, nasopharyngitis, extremity pain, injection site reactions, depression, migraine, and pharyngitis.

“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,” Herson Quinones, Vice President of Specialty and Pipeline US Medical Affairs at GSK, stated. “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.”