Apellis Wins FDA Approval for EMPAVELI in Rare Kidney Diseases
Apellis Pharmaceuticals Inc. has received FDA approval for EMPAVELI® (pegcetacoplan) as the first treatment for C3 glomerulopathy and primary immune complex membranoproliferative glomerulonephritis in patients aged 12 and older. This approval follows positive results from the Phase 3 VALIANT study. In the EU, Apellis' partner Sobi® expects an opinion from the European Medicines Agency's CHMP by year-end.
Apellis Pharmaceuticals Inc. has received FDA approval for EMPAVELI® (pegcetacoplan) as the first treatment for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients aged 12 and older. The approval follows positive results from the Phase 3 VALIANT study, which demonstrated significant reductions in proteinuria, stabilization of kidney function, and substantial clearance of C3 deposits. In the European Union, Apellis’ partner Sobi® anticipates an opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) before the end of the year. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Apellis Pharmaceuticals Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9595472-en) on December 03, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT)
