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# Apellis Files Empaveli sNDA in Rare Kidney Diseases
- URL: https://www.fdaweb.com/apellis-files-empaveli-snda-in-rare-kidney-diseases/
- Published: 2025-04-01T12:00:00.000Z
- Updated: 2026-09-14T14:56:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158935

FDA has accepted for priority review an Apellis Pharmaceuticals supplemental NDA for Empaveli (pegcetacoplan) for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), which are severe and rare kidney diseases. The agency has set a user fee review action target date of 7/28\. “Empaveli demonstrated clinically meaningful benefits across all three key markers of disease — unprecedented proteinuria reductions, stabilization of kidney function, and substantial clearance of C3c staining,” a company release says.

C3G and primary IC-MPGN are rare and debilitating kidney diseases that can lead to kidney failure, according to Apellis. Excessive C3c deposits are a key marker of disease activity, which can lead to kidney inflammation, damage, and failure.

The submission is based on data from the company’s Phase 3 VALIANT study, which met its primary endpoint of demonstrating a statistically significant 68% proteinuria reduction in Empaveli-treated patients compared to placebo, according to the company. Also, Empaveli-treated patients achieved stabilization of kidney function, and a substantial proportion of Empaveli-treated patients achieved a reduction in C3c staining intensity, it says.