Apellis Pharma Says FDA Granted Priority Review To SNDA For Empaveli For C3G And Primary IC-MPGN

(RTTNews) - Apellis Pharmaceuticals, Inc. (APLS) Tuesday said that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation for the supplemental New Drug Application (sNDA) for empaveli for the treatment of C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), severe and rare kidney diseases.

The Prescription Drug User Fee Act (PDUFA) target action date or the date on which a decision from the regulator is expected, is on July 28, 2025.

The sNDA submission was supported by positive results from Phase 3 study of empaveli dubbed VALIANT. The study met its primary goal by showing a statistically significant 68 percent proteinuria reduction in empaveli-treated patients compared to placebo.