Apellis announces FDA acceptance, priority review of sNDA for EMPAVELI

Apellis (APLS) Pharmaceuticals announced that the U.S. Food and Drug Administration, FDA, has accepted and granted Priority Review designation of the supplemental New Drug Application, sNDA, for EMPAVELI for C3 glomerulopathy and primary immune complex membranoproliferative glomerulonephritis, IC-MPGN, which are severe and rare kidney diseases. The Prescription Drug User Fee Act, PDUFA, target action date is July 28, 2025. “EMPAVELI demonstrated clinically meaningful benefits across all three key markers of disease – unprecedented proteinuria reductions, stabilization of kidney function, and substantial clearance of C3c staining,” said Bradley P. Dixon, M.D., FASN, professor of pediatrics and medicine, University of Colorado School of Medicine, and co-investigator of the VALIANT study. “Efficacy is critically important when treating C3G and IC-MPGN given the high risk of progression to kidney failure. As a disease-modifying therapy, EMPAVELI has the potential to make a life-changing difference for patients, if approved.”