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The New England Journal of Medicine Publishes Positive Phase 3 VALIANT Results of EMPAVELI® (pegcetacoplan) for C3G and Primary IC-MPGN
Robust and clinically meaningful benefits across all three key markers of disease – 68% reduction in proteinuria, stabilization of kidney function, and
About this update from Apellis Pharmaceuticals, Inc.
[{"type":"text","content":"Robust and clinically meaningful benefits across all three key markers of disease – 68% reduction in proteinuria, stabilization of kidney function, and substantial clearance of C3 depositsConsistent results across adolescent and adult patients with C3G and primary IC-MPGN, including patients with C3G recurring after transplantEMPAVELI is the first FDA-approved treatment for C3G and primary IC-MPGN patients 12 and older WALTHAM, Mass., Dec. 03, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that The New England Journal of Medicine (NEJM) published positive results from the Phase 3 VALIANT study investigating EMPAVELI® (pegcetacoplan) for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), which are severe and rare kidney diseases. “The positive data published in the New England Journal of Medicine underscore the unprecedented benefits of EMPAVELI across all three key markers of disease,” said Carla Nester, M.D., MSA, FASN, senior author, professor of internal medicine and pediatrics and director of pediatric nephrology, University of Iowa Stead Family Children's Hospital. “C3G and primary IC-MPGN often lead to kidney failure, and the need for a kidney transplant or dialysis can be devastating. EMPAVELI represents a significant advance in treatment, and I’m thrilled that patients now have access to this important medicine.” The data published in NEJM highlight the positive Phase 3 VALIANT results at Week 26, which were consistent across adolescent and adult patients with C3G and primary IC-MPGN, including patients with C3G recurring after transplant. EMPAVELI demonstrated benefits across all three key markers of disease: Proteinuria reduction: The study met its primary endpoint, demonstrating a statistically significant 68% (p","length":2363,"tagName":"div"}]