Belimumab has been approved for use in adult patients since 2011, and GSK’s application for belimumab use in pediatric patients was granted the FDA’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’s Priority Review designation.
“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.
While childhood-onset SLE is rare, when diagnosed, it is generally more active in children and adolescents than adult patients, particularly in how it impacts organs and the central nervous system. As a result of the disease starting early in life, pediatric patients with SLE are at a higher risk for developing increased organ damage and complications from the disease as well as adverse events from the life-long treatments usually required.
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.
The most common adverse effects in patients included nausea, diarrhea and fever. Patients also commonly experienced infusion reactions. Health care professionals are advised to pre-treat patients with an antihistamine.
The doctor and patient information for GSK’s belimumab product includes a warning for mortality, serious infections, hypersensitivity and depression, based on data from the clinical studies in adults with SLE. The drug should not be administered with live vaccines. The manufacturer is required to provide a Medication Guide to inform patients of the risks associated with the drug.
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.