Sobi® and Apellis Pharmaceuticals 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.
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<0.0001) proteinuria reduction in pegcetacoplan-treated patients compared to placebo. At week 26, results were consistent agross subgroups, including disease type, age, and transplant status.
