Shots:
- The EC approved Aspaveli (pegcetacoplan) for pts (≥12yrs.) with C3 glomerulopathy or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), to be used with a RAS inhibitor unless such therapy is contraindicated or not tolerated
- Approval was based on P-III (VALIANT) trial assessing Aspaveli(twice weekly) vs PBO in C3G or primary IC-MPGN pts (≥12yrs., n=124) for 26wks. followed by 26wk. open-label period, where all pts received Aspaveli
- Trial showed improvement across three key markers of disease, incl. proteinuria reduction, stabilized kidney function & substantial clearance of C3 deposits; results were published in The NEJM
Ref: PRnewswire | Image: Sobi |Press Release
Related News: Sobi Reports the CHMP Positive Opinion of Aspaveli for C3 Glomerulopathy and Primary IC-MPGN
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