The US Food and Drug Administration has approved GlaxoSmithKline’s Benlysta (belimumab) intravenous (IV) infusion to treat children with systemic lupus erythematosus (SLE).
Lupus is a chronic disease that causes inflammation and damages various body tissues.
The FDA’s Center for Drug Evaluation and Research director Janet Woodcock said: “The agency expedited the review and approval of this application because Benlysta IV fulfils an unmet need for therapies, specifically in pediatric patients with SLE.
“While there is no cure for lupus, treatment can help our youngest patients control their disease with the hope of improving their quality of life and lowering their risk of long-term organ damage and disability.”
GlaxoSmithKline evaluated the efficacy of Benlysta IV over a period of 52 weeks in 93 pediatric patients with SLE.
The trial’s primary endpoint was monitored using the SLE response index. It found that the proportion of pediatric patients achieving a positive SLE response was higher in pediatric patients receiving Benlysta IV and standard therapy compared to placebo plus standard therapy.
In addition, pediatric patients that received Benlysta IV plus standard therapy reported a lower risk of experiencing severe flares, and longer duration of time until a severe flare.
Benlysta has been approved to treat adult patients since 2011.
When diagnosed, childhood-onset SLE is generally more active in children and adolescents than adult patients.
As the disease starts early in life, pediatric patients with SLE are at a higher risk for developing increased organ damage and complications.