Apellis Pharmaceuticals (APLS) and Sobi said Thursday that the European Medicines Agency has validated an indication extension application for Aspaveli to treat C3 glomerulopathy and primary immune complex membranoproliferative glomerulonephritis.
The submission was based on the results from a phase 3 trial that met its primary endpoint by reducing proteinuria in pegcetacoplan-treated patients by 68% as compared to placebo, the companies added.
C3 glomerulopathy and primary immune complex membranoproliferative glomerulonephritis are two kinds of chronic kidney diseases without approved treatments.
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