EC approves Aspaveli for C3G and primary IC-MPGN
Swedish Orphan Biovitrum (STO: SOBI) has announced that the European Commission (EC) has approved Aspaveli (pegcetacoplan) for adults and adolescents aged 12 to 17 years with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) in combination with a renin-angiotensin system (RAS) inhibitor, unless RAS inhibitor treatment is not tolerated or contraindicated.
The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) issued last month.
Aspaveli is a targeted C3/C3b inhibitor designed to regulate excessive complement activation, a key driver of C3G and primary IC-MPGN. These conditions are associated with progressive kidney damage and limited treatment options.
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