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
Biogen published adolescent subgroup results from the Phase 3 VALIANT study in the Clinical Journal of the American Society of Nephrology, showing EMPAVELI (pegcetacoplan) achieved a 75% relative reduction in proteinuria versus placebo in adolescents aged 12 to 17 with C3G or primary IC-MPGN. Among the 55-patient adolescent cohort at Week 26, 71% of EMPAVELI-treated patients achieved at least a 50% proteinuria reduction versus 4% on placebo, and 57% achieved both stable kidney function and a 50%+ proteinuria reduction versus 4%; safety was consistent with the overall VALIANT population of 124 patients.
Key figures
- Drug Name
- EMPAVELI (pegcetacoplan)
- Phase Of Trial
- Phase 3
- Indication
- C3 glomerulopathy (C3G) and primary IC-MPGN in patients 12 years and older
- Trial name
- VALIANT
- Label status
- recent FDA label expansion; EMPAVELI is first and only approved therapy for adolescents with C3G and primary IC-MPGN
- Trial registration
- NCT05067127
- Adolescent cohort n
- 55
- Total trial patients
- 124
- Proteinuria relative reduction
- 75% vs placebo (95% CI: 59%-84%; nominal p<0.001) at Week 26
- Proteinuria 50pct responder rate
- 71% EMPAVELI vs 4% placebo (nominal p<0.001)
- Composite stable kidney function and 50pct proteinuria reduction
- 57% EMPAVELI vs 4% placebo (nominal p=0.002)
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