FDA approves belimumab for lupus in children as young as 5

  • FDA

  • Miriam Davis, PhD
  • Clinical Essentials
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Takeaway

  • 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.

Key points

  • 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.