Shots:
- The US FDA has accepted sNDA & granted priority review to Empaveli for C3 glomerulopathy (C3G) & primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) pts (PDUFA: Jul 28, 2025)
- Submission was backed by P-III (VALIANT) trial assessing Empaveli (Q2W) vs PBO in C3G & primary IC-MPGN pts (≥12yrs., n=124) for 26wks. followed by 26wk. open-label period, where all pts received Empaveli
- Trial met its 1EP of proteinuria reduction by 68% & demonstrated stabilized kidney function per eGFR, with 71% of Empaveli-treated pts achieving complete clearance of C3c staining
Ref: Apellis | Image: Apellis
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