Posted by Michael Wonder on 02 Apr 2025
Apellis announces FDA acceptance and priority review of the supplemental new drug application for Empaveli (pegcetacoplan) for C3G and primary IC-MPGN
1 April 2025 - PDUFA target action date is 28 July 2025.
Apellis Pharmaceuticals today announced that the US FDA has accepted and granted priority review designation of the supplemental new drug application for Empaveli (pegcetacoplan) for C3 glomerulopathy and primary immune complex membranoproliferative glomerulonephritis, which are severe and rare kidney diseases.
