FDA Approves First Treatment for Pediatric SLE

The US Food and Drug Administration has approved Benlysta (belimumab) intravenous (IV) infusion for the treatment of children with systemic lupus erythematosus (SLE). 

The approval comes after results from a 52-week study of 93 pediatric participants showed more participants who received belimumab IV plus standard therapy reached the composite primary endpoint, the SLE response index, than those who received placebo plus standard therapy. 

Participants in the belimumab group also had a lower risk for severe flare and longer duration of time until a severe flare (160 days vs 82 days). The overall safety and pharmacokinetic profiles of belimumab IV among pediatric participants were consistent with those in adults with SLE.

“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,” said Janet Woodcock, MD director of the FDA’s Center for Drug Evaluation and Research. 

Doctor and patient information included with belimumab provided a warning for mortality, serious infections, hypersensitivity, and depression, based on data from clinical studies in adults with SLE.

Belimumab was first approved for use in adults with SLE in 2011.

—Colleen Murphy

Reference:

FDA approves first treatment for pediatric patients with lupus [press release]. Silver Springs, MD: US Food & Drug Administration; April 26, 2019. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-pediatric-patients-lupus?utm_campaign=042619_PR_FDA%20approves%20first%20pediatric%20treatment%20for%20lupus&utm_medium=email&utm_source=Eloqua. Accessed April 29, 2019.