Biogen Reports Significant Reduction in Proteinuria for Adolescents with C3G or IC-MPGN
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CAMBRIDGE, Mass., Sept. 17, 2026 (GLOBE NEWSWIRE), Biogen Inc. today announced the publication of results from a prespecified adolescent subgroup analysis of the Phase 3 VALIANT study evaluating EMPAVELI® (pegcetacoplan) in the Clinical Journal of the American Society of Nephrology (CJASN). The study showed that EMPAVELI-treated adolescents achieved a 75% relative reduction in proteinuria within 6 months compared to placebo. This significant reduction was first presented at the 2025 Annual Meeting of the European Society of Paediatric Nephrology (ESPN).
The analysis, which included a cohort of 55 adolescents aged 12 to 17 years with C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), demonstrated that 71% of adolescents treated with EMPAVELI achieved at least a 50% reduction in proteinuria, compared to only 4% of those receiving placebo. Additionally, 57% of EMPAVELI-treated adolescents achieved both stable kidney function and at least a 50% reduction in proteinuria, compared to 4% of those receiving placebo.
The publication follows a recent FDA label update that expanded EMPAVELI’s indication to include reducing the loss of kidney function in patients 12 years and older, in addition to reducing proteinuria. The label update was based on 52-week efficacy and safety data from the VALIANT study, which showed substantial reductions in proteinuria and sustained preservation of kidney function, as measured by estimated glomerular filtration rate (eGFR).
C3G and primary IC-MPGN are rare, chronic, complement-mediated kidney diseases that often begin early in life. Approximately half of patients with C3G are diagnosed before age 18, while the median age at diagnosis for primary IC-MPGN is approximately 21 years. Despite standard-of-care treatment, approximately 20% of children with C3G or primary IC-MPGN progress to kidney failure within 10 to 15 years of diagnosis.
“The VALIANT results show substantial reductions in proteinuria and stabilization of kidney function in adolescents, consistent with what we observed in the broader population. These findings are especially encouraging for young patients who may otherwise face a lifetime of progressive kidney disease leading to a potential kidney transplant.”
EMPAVELI was well tolerated in adolescents, with a safety profile consistent with the overall VALIANT population. The study included both adolescent and adult patients with native kidney disease or post-transplant disease recurrence. Participants were randomized to receive EMPAVELI or placebo twice weekly for 26 weeks, followed by a 40-day open-label period in which all patients received EMPAVELI.
About the VALIANT Study VALIANT (NCT05067127) was a randomized, placebo-controlled, double-blind, multicenter Phase 3 study evaluating the efficacy and safety of EMPAVELI in 124 patients aged 12 years and older with C3G or primary IC-MPGN. The trial included both adolescent and adult patients with native kidney disease or post-transplant disease recurrence. Participants were randomized to receive EMPAVELI or placebo twice weekly for 26 weeks, followed by a 40-day open-label period in which all patients received EMPAVELI. The primary endpoint was the change in urine protein-to-creatinine ratio (UPCR) at Week 26 compared with baseline.
About Biogen Inc. Founded in 1978, Biogen is a global biotechnology company dedicated to developing innovative therapies for people living with serious diseases. In the fiscal year ended December 31, 2025, Biogen reported a net product revenue of $12.3 billion.