Shots:
- The US FDA has approved Empaveli (pegcetacoplan) for C3 glomerulopathy (C3G) & primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) pts (≥12yrs.)
- Approval was based on 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 C3 deposits at 6mos.
Ref: GlobeNewswire | Image: Apellis Pharmaceuticals | Press Release
Related News:- Apellis Pharmaceuticals and Sobi Report P-III (VALIANT) Trial Data of Empaveli for C3 Glomerulopathy (C3G) and Primary IC-MPGN
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