Apellis Pharmaceuticals Inc., in collaboration with Sobi, announced that the marketing applications for EMPAVELI® (pegcetacoplan) are currently under review by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency $(EMA)$. This review pertains to the treatment's use in addressing rare kidney diseases, specifically C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN). The announcement follows the presentation of new data at the European Renal Association Congress, highlighting sustained efficacy and safety in a Phase 3 study. The companies are hopeful for an FDA decision by the upcoming summer, aiming to quickly make EMPAVELI available to patients with these severe conditions.
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