GSK gets USFDA nod for Benlysta for children with active lupus nephritis
London: GSK plc has announced that the US Food and Drug Administration (USFDA) has approved Benlysta (belimumab) for the treatment of children aged 5 to 17 with active lupus nephritis (LN) who are receiving standard therapy.
Lupus nephritis is a serious inflammation of the kidneys caused by lupus, which can lead to end-stage kidney disease, requiring dialysis or a kidney transplant. The approval extends the current indication in the US to include both lupus and active LN for the intravenous formulation in the pediatric patient population.
BENLYSTA, a BLyS-specific inhibitor, is a human monoclonal antibody that binds to soluble BLyS. BENLYSTA does not bind B cells directly. By binding BLyS, BENLYSTA 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, it is the first and only approved biologic for both SLE and LN in more than 50 years.
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," 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."
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