Shots:
- The CHMP has recommended Sobi‘s Aspaveli (pegcetacoplan) for C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) pts (≥12yrs.), with EC decision expected in Q1’26
- Opinion was based on P-III (VALIANT) trial assessing Aspaveli(Q2W) 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: Sobi| Image: Sobi |Press Release
Related News: Sobi to Acquire Arthrosi Therapeutics for ~$1.5B
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