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news.GlaxoSmithKline (GSK) has secured approval from the US Food and Drug Administration (FDA) for its Benlysta (belimumab) intravenous (IV) infusion to treat children with systemic lupus erythematosus (SLE).
Image: GSK's corporate headquarters in Brentford, London. Photo: courtesy of GlaxoSmithKline plc / flickr.
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SLE, simply referred as lupus, is a serious chronic disease that causes inflammation and damage to different body tissues and organs.
The FDA provided priority review designation to the antibody, which is a prescription medication used to treat patients with SLE who are receiving other lupus medicines.
FDA said that Benlysta is the first treatment approved by the regulator to treat pediatric patients with SLE. Since 2011, Benlysta has been approved for use in adult patients.
Benlysta IV’s efficacy to treat SLE in pediatric patients was assessed in more than 52 weeks in 93 pediatric patients with SLE.
The proportion of pediatric patients achieving the composite primary endpoint, the SLE response index (SRI-4), was higher in pediatric patients receiving Benlysta IV plus standard therapy compared against placebo plus standard therapy, said FDA.
Pediatric patients who secured Benlysta IV plus standard therapy also experienced a lower risk of severe flare.
The safety and pharmacokinetic profiles of drug in pediatric patients have been in line with those in adults with SLE.
According to FDA, Benlysta’s doctor and patient information is comprised of a warning for mortality, serious infections, hypersensitivity and depression, based on data from the clinical studies in adults with SLE.
GSK said that the efficacy of the antibody has not been assessed in patients with severe active lupus nephritis or severe active central nervous system lupus, as well as not been studied in combination with other biologics or intravenous cyclophosphamide.
The FDA’s Center for Drug Evaluation and Research director Dr 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.”
