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Phase 3 Pediatric EMPAVELI Data Published in Clinical Journal of the American Society of Nephrology Show Reduction in Proteinuria and Stabilized Kidney Function in Adolescents with C3G or Primary IC-MPGN

BIIB
  • Biogen announced publication of adolescent subgroup results from the Phase 3 VALIANT study in the Clinical Journal of the American Society of Nephrology.
  • EMPAVELI-treated adolescents (ages 12-17) achieved a 75% relative reduction in proteinuria versus placebo within 6 months.
  • 71% of adolescents on EMPAVELI achieved at least a 50% reduction in proteinuria compared to 4% on placebo.
  • 57% of EMPAVELI-treated adolescents achieved both stable kidney function & at least a 50% reduction in proteinuria versus 4% on placebo.
  • The findings support the recent FDA label expansion making EMPAVELI the only approved treatment to reduce both proteinuria & loss of kidney function in patients aged 12 years & older.
  • The VALIANT study included 124 patients aged 12 years & older with C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN).
  • Adolescents represented nearly half of the VALIANT study population, creating one of the largest randomized datasets for these conditions in this age group.
  • EMPAVELI demonstrated a well-tolerated safety profile in adolescents consistent with the overall study population.
  • C3G & primary IC-MPGN are rare, complement-mediated kidney diseases that often begin early in life & can lead to kidney failure without effective treatment.
  • EMPAVELI carries a Boxed Warning for serious infections caused by encapsulated bacteria, requiring vaccination at least 2 weeks prior to initiation.
  • The drug is available only through a restricted REMS program due to infection risks, mandating prescriber enrollment & patient counseling.
  • Most common adverse reactions in patients aged 12 years & older included infusion-site reactions, pyrexia, nasopharyngitis, influenza, cough, & nausea.
  • EMPAVELI may cause embryo-fetal harm, requiring pregnancy testing & effective contraception for females of reproductive potential during treatment.