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October 23, 2020 07:00pm
By Sara Karlovitch, Assistant Editor
This is the first time that the FDA has approved a treatment for pediatric patients with SLE. Belimumab has been approved for use in adult patients since 2011. GSKâ€™s application for belimumab use in pediatric patients was granted the FDAâ€™s Priority Review designation.
Officials with the FDA today approved belimumab (Benlysta, GlaxoSmithKline[GSK]) intravenous (IV) infusion for treatment of children with systemic lupus erythematosus (SLE).
This is the first time that the FDA has approved a treatment for pediatric patients with SLE. Belimumab has been approved for use in adult patients since 2011. GSK’s application for belimumab use in pediatric patients was granted the FDA’sPriority Reviewdesignation.
“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,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, in a prepared statement.
The efficacy of belimumab for the treatment of SLE in pediatric patients was studied over 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 belimumab plus standard therapy compared to placebo plus standard therapy. Pediatric patients who received belimumab plus standard therapy also had a lower risk of experiencing a severe flare, as well as longer duration of time until a severe flare (160 days versus 82 days). The drug’s safety and pharmacokinetic profiles in pediatric patients were consistent with those in adults with SLE.
This article was originally posted onPharmacy Times.
FDA approves first treatment for pediatric patients with lupus [news release]. Silver Spring, MD; April 26, 2019: FDA website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm636756.htm. Accessed April 26, 2019.