European Commission Approves Aspaveli by Sobi for Treatment of C3G and Primary IC-MPGN

Reuters01-16
European Commission Approves Aspaveli by Sobi for Treatment of C3G and Primary IC-MPGN

Swedish Orphan Biovitrum AB (Sobi) has received European Commission approval for Aspaveli® (pegcetacoplan) for the treatment of C3 glomerulopathy (C3G) and primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) in patients aged 12 years and older. Aspaveli is the first approved treatment for primary IC-MPGN and the first therapy indicated for both C3G and primary IC-MPGN in adolescent and adult patients. The approval is supported by positive results from the Phase 3 VALIANT study, which demonstrated benefits in reducing proteinuria, stabilising kidney function, and clearing C3 deposits. Sobi and Apellis Pharmaceuticals, Inc. have global co-development rights for systemic pegcetacoplan.

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