- The FDA has approved an expanded indication for belimumab (Benlysta), allowing its use in children aged 5-17 years with systemic lupus erythematosus (SLE).
- This move marks the first time FDA has approved a drug specifically for pediatric SLE.
- Belimumab was approved for adult use in 2011.
Why this matters
- 5000-10,000 children in the U.S. are diagnosed with SLE.
- Childhood-onset SLE is generally more active, damaging organs such as the kidney and the central nervous system.
- Prescribing information is here.
- Belimumab is a B-lymphocyte stimulator protein inhibitor whose mechanism is thought to decrease abnormal B cells.
- Belimumab's fast-track approval for children was based on the PLUTO study.
- Results showed that adding 10 mg/kg intravenous belimumab every 4 weeks to standard therapy improved the likelihood of achieving the composite primary outcome, the SLE responder index with ≥50% improvement (52.8% vs 43.6%).
- Data also showed 62% fewer severe flares, and longer duration of time to severe flare (160 vs 82 days).
- The label carries a warning for mortality, serious infections, hypersensitivity, and depression, based on adult studies. The manufacturer is required by FDA to provide a guide informing patients of risks.