Apellis and Sobi Announce EMA Validation of Indication Extension Application for Aspaveli® (pegcetacoplan) for C3G and Primary IC-MPGN

WALTHAM, Mass. and STOCKHOLM, Sweden, Feb. 20, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) and Sobi® (STO:SOBI) today announced the European Medicines Agency (EMA) has validated an indication extension application for Aspaveli® (pegcetacoplan) for the treatment of C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), which are rare, chronic kidney diseases with no approved treatments.

“C3G and IC-MPGN are severe and life-threatening kidney conditions, often leading to kidney failure and requiring a kidney transplant or dialysis for life,” said Lydia Abad-Franch, M.D., head of R&D and medical affairs and chief medical officer at Sobi. “With no approved treatments currently available, this important milestone reflects our dedication to improving outcomes for those affected by these rare kidney conditions.”

The submission includes positive data from the Phase 3 VALIANT study. The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful 68% (p