FDA Reviews Kidney Disease Drug From Apellis Pharmaceuticals

The supplemental application submission supported by Phase 3 VALIANT results at Week 26: The U.S. Food and Drug Administration (FDA) on Tuesday accepted and granted Priority Review designation to Apellis Pharmaceuticals, Inc.'s APLS supplemental New Drug Application (sNDA) for Empaveli (pegcetacoplan) for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN). C3G and primary IC-MPGN are rare kidney diseases. Excessive C3c deposits are a key marker of disease a ...