GSK’s Benlysta Bags US Approval for Lupus Complication

GlaxoSmithKline has announced the US FDA approval of Benlysta (belimumab) for the treatment of active lupus nephritis (LN) in children aged 5 to 17 who are on active therapy. 

The approval makes Benlysta the first approved treatment for pediatric LN, building on its 2020 approval for adult LN. Benlysta was originally approved in 2011 for systemic lupus erythematosus (SLE), or lupus.

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Treatment for a Serious Complication 

Lupus is an autoimmune disease where the immune system attacks multiple tissues and organs. Lupus nephritis occurs when lupus autoantibodies affect the kidney, causing inflammation that may lead to impaired kidney function or even kidney failure. 

Most cases of pediatric LN occur within the first two years of their initial diagnosis, said Stevan W. Gibson, President and CEO of Lupus Foundation of America. 

Treatment options for children with LN were mainly limited to non-selective immunosuppressants and corticosteroids. 

Benlysta is a human monoclonal antibody that targets and inhibits B lymphocyte stimulator (BLyS), an important cytokine factor in the survival and apoptosis of B cells. This reduces the differentiation of B cells into autoantibody-producing plasma cells, subsequently lessening autoantibody attack on the kidney. 

“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.

Benlysta brought in £297 million in the second quarter of 2022, growing by double digits due to strong US demand.

Author

Joy Lin

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